Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- KIPFormulations, Balanced Salt Solutions1Product Code
- KIQKit, Culture, Chromosome1Product Code
- KIRCells, Animal And Human, Cultured1Product Code
- KISSera, Animal And Human1Product Code
- KITMedia And Components, Synthetic Cell And Tissue Culture1Product Code
- K892938AMNIO-GROW TM1Cleared 510(K)
- K890701ENDOTHELIAL GROWTH MEDIUM (EGM)1Cleared 510(K)
- K890700MELANOCYTE GROWTH MEDIUM (MGM)1Cleared 510(K)
- K890482ABC, ABC-1X, ABC(TM)1Cleared 510(K)
- K884654ALPHACALF SERUM1Cleared 510(K)
- K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D97851Cleared 510(K)
- K884573HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H48911Cleared 510(K)
- K884572RPMI-1640 HYBRI-MAX, PROD. NO. R53821Cleared 510(K)
- K883065ALLOPREP SYSTEM1Cleared 510(K)
- K884031FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT1Cleared 510(K)
- K883951MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)1Cleared 510(K)
- K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)1Cleared 510(K)
- K883626EX-CELL 301, CATALOG NO. 210-35771Cleared 510(K)
- K883632EX-CELL 300TM, CATALOG NO. 210-35751Cleared 510(K)
- K883631EX-CELL 300TM, CATALOG # 210-35791Cleared 510(K)
- K883630RPMI-1640 MEDIUM, CATALOG NO. 210-35251Cleared 510(K)
- K883629HANK'S BALANCED SALTS (HBSS) CATALOG # 210-30131Cleared 510(K)
- K883628MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-20511Cleared 510(K)
- K883627MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-21501Cleared 510(K)
- K883625EX-CELL 301, CATALOG NO. 200-36511Cleared 510(K)
- K883624EX-CELL 300TM, CATALOG NO. 200-36011Cleared 510(K)
- K883623EX-CELL 300TM, CATALOG NO. 200-36001Cleared 510(K)
- K883451SFRE 199-1 MEDIUM, CATALOG NO. 200-21911Cleared 510(K)
- K883501MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531)1Cleared 510(K)
- K883500MCCOY'S 5A MEDIUM 10X NO. 210-35321Cleared 510(K)
- K883499MEDIUM 199, 10X, CATALOG NO. 210-35571Cleared 510(K)
- K883498FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-11231Cleared 510(K)
- K883497MEDIUM 199, 10X CATALOG NO. 210-35561Cleared 510(K)
- K883496MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-35171Cleared 510(K)
- K883495MEDIUM 199, 10X, CATALOG NO. 210-35551Cleared 510(K)
- K883502FETAL BOVINE SERUM, DEFINED NO. 110-11211Cleared 510(K)
- K883450SFRE 199-2 MEDIUM, CATALOG NO. 200-21921Cleared 510(K)
- K883449MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-20481Cleared 510(K)
- K883448MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-20461Cleared 510(K)
- K883447MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-35111Cleared 510(K)
- K883446FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-11221Cleared 510(K)
- K883445HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-30121Cleared 510(K)
- K883370FISCHER'S MEDIUM CATALOG NO. 210-40071Cleared 510(K)
- K883369L-15 MEDIUM, CATALOG NO. 210-40041Cleared 510(K)
- K883368NEWBORN CALF SERUM, CATALOG NO. 110-11301Cleared 510(K)
- K883367CALF SERUM, CATALOG NO. 110-11251Cleared 510(K)
- K883366MEDIUM 199, CATALOG NO. 200-20311Cleared 510(K)
- K883365HORSE SERUM, ABATTOIR, NO. 110-11121Cleared 510(K)
- K883364ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-35051Cleared 510(K)
- K883363ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-21051Cleared 510(K)
- K883362L-15 MEDIUM, CATALOG NO. 200-20211Cleared 510(K)
- K883292BOVINE SERUM, CAT. LNO. 110-11151Cleared 510(K)
- K883291DONOR HORSE SERUM, CAT. NO. 110-11101Cleared 510(K)
- K883290DONOR BOVINE SERUM, CAT. NO. 110-11161Cleared 510(K)
- K883289CALF SERUM, HEAT INACTIVATED, CAT. # 110-11271Cleared 510(K)
- K883288DONOR HORSE SERUM, HEAT INACTIVATED, #110-11131Cleared 510(K)
- K883287CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-11261Cleared 510(K)
- K883286NEWBORN CALF SERUM, HEAT INACTIVATED # 110-11311Cleared 510(K)
- K883285FETAL BOVINE SERUM, CAT. NO. 110-11201Cleared 510(K)
- K883141RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-21201Cleared 510(K)
- K883140MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-20901Cleared 510(K)
- K883139MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-21101Cleared 510(K)
- K883138CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-21771Cleared 510(K)
- K882996DULBECCO'S PHOSPHATE BUFFERED SALINE NO.210-30221Cleared 510(K)
- K882997(DME/F-12 1:1), CATALOG NO. 200-21001Cleared 510(K)
- K882995FISCHER'S MEDIUM NO. 200-21881Cleared 510(K)
- K882994DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-30211Cleared 510(K)
- K882993NUTRIENT MIXTURE F-12 (HAM) NO. 200-20711Cleared 510(K)
- K882992MINIMUM ESSENTIAL MEDIUM, ALPHA MODI. NO.200-20911Cleared 510(K)
- K882983MEDIUM 199, CATALOG NO. 210-35351Cleared 510(K)
- K882991NUTRIENT MIXTURE F-12 (HAT VARIATION) NO. 200-20701Cleared 510(K)
- K882990RPMI-1640 BAKER'S MODIFICATION NO. 200-20781Cleared 510(K)
- K882989DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-35021Cleared 510(K)
- K882988DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-35401Cleared 510(K)
- K882987DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-20091Cleared 510(K)
- K882965KREBS-HENSELEIT BICARBONATE BUFFER NO. K37531Cleared 510(K)
- K882986MCCOY'S 5A MEDIUM NO. 210-35301Cleared 510(K)
- K882985FISCHER'S MEDIUM NO. 200-21841Cleared 510(K)
- K882984MEDIUM 199, NO. 200-20351Cleared 510(K)
- K882849DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-35001Cleared 510(K)
- K882846DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-35011Cleared 510(K)
- K882847MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-35151Cleared 510(K)
- K882848RPMI-1640 MEDIUM, CATALOG NO. 210-35211Cleared 510(K)
- K882850NUTRIENT MIXTURE F-10 (HAM) NO. 210-35501Cleared 510(K)
- K882851RPMI-1640 MEDIUM, CATALOG NO. 210-35231Cleared 510(K)
- K882853RPMI-1640 MEDIUM, CATALOG NO. 210-35201Cleared 510(K)
- K882854MEDIUM 199, CATALOG NO. 210-35361Cleared 510(K)
- K882860MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-35101Cleared 510(K)
- K882861MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-35141Cleared 510(K)
- K882863MINIMUM ESSENTIAL MEDIUM EAGLE (MEM) NO. 210-35121Cleared 510(K)
- K882837DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-21831Cleared 510(K)
- K882862DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 200-25301Cleared 510(K)
- K882859DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-30201Cleared 510(K)
- K882858NUTRIENT MIXTURE F-12 (HAM), NO. 210-35511Cleared 510(K)
- K882857HANKS' BALANCED SALTS NO. 210-30101Cleared 510(K)
- K882856EARLE'S BALANCED SALT SOLUTION NO. 210-30051Cleared 510(K)
- K882855HANKS' BALANCED SALT SOLUTION NO. 210-30151Cleared 510(K)
- K882852DULBECCO'S PHOSPHATE BUFFERED SALINE, NO 200-25251Cleared 510(K)
- K882866EARLE'S BALANCED SALT SOLUTION (EBSS) NO. 210-30001Cleared 510(K)
- K882865DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-30251Cleared 510(K)
- K882864HANKS' BALANCED SALT SOLUTION (HBSS) NO. 210-30111Cleared 510(K)
- K882840HANK'S BALANCED SALTS (HBSS) NO. 200-25201Cleared 510(K)
- K882842EARLE'S BALANCED SALTS (EBSS) NO. 200-25051Cleared 510(K)
- K882843HANK'S BALANCED SALTS NO. 200-25151Cleared 510(K)
- K882844HANK'S BALANCED SALTS NO. 200-25101Cleared 510(K)
- K882845EARLE'S BALANCED SALTS NO. 200-25001Cleared 510(K)
- K882838MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-21801Cleared 510(K)
- K882839EARLE'S BALANCED SALTS (EBSS) NO. 200-25061Cleared 510(K)
- K882841HANK'S BALANCED SALTS (HBSS) NO. 200-25211Cleared 510(K)
- K882787DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-20191Cleared 510(K)
- K882781RPMI-1640 MEDIUM, CATALOG NO. 200-20771Cleared 510(K)
- K882782RPMI-1640 MEDIUM, CATALOG NO. 200-20811Cleared 510(K)
- K882783BASAL MEDIUM EAGLE (BME) DIPLOID, NO. 200-20431Cleared 510(K)
- K882784RPMI-1640 CATALOG NO. 200-21211Cleared 510(K)
- K882785DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-20061Cleared 510(K)
- K882786RPMI-1640 CATALOG NO. 200-20791Cleared 510(K)
- K882788MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-20471Cleared 510(K)
- K882790MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-20421Cleared 510(K)
- K882779BASAL MEDIUM EAGLE CATALOG NO. 200-20521Cleared 510(K)
- K882780NUTRIENT MIXTURE F-10 (HAM), NO. 200-20611Cleared 510(K)
- K882775DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-20231Cleared 510(K)
- K882776DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-20141Cleared 510(K)
- K882777DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-20041Cleared 510(K)
- K882778BASAL MEDIUM EAGEL, CATALOG NO. 200-20441Cleared 510(K)
- K882774DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-20021Cleared 510(K)
- K882806MEDIUM 199, CATALOG NO. 200-20321Cleared 510(K)
- K882808RPMI-1640 MEDIUM, CATALOG NO. 200-20761Cleared 510(K)
- K882807DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-20111Cleared 510(K)
- K882789COON'S MEDIUM F-12, CATALOG NO. 200-20661Cleared 510(K)
- K882773MCCOY'S 5A MEDIUM, CATA NO. 200-20261Cleared 510(K)
- K880691EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM1Cleared 510(K)
- K880999EPIPACK1Cleared 510(K)
- K881000KERATINOCYTE GROWTH MEDIUM (KGM)1Cleared 510(K)
- K873090MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI.1Cleared 510(K)
- K873095(MEM) EAGLE NO. M3149 W/HANKS' SALTS1Cleared 510(K)
- K873094(MEM) EAGLE NO. M7399 W/EARLE'S SALTS1Cleared 510(K)
- K873093(MEM) EAGLE NO. M3024 W/EARLE'S SALTS1Cleared 510(K)
- K873092RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU.1Cleared 510(K)
- K873091AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB.1Cleared 510(K)
- K873084RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-20801Cleared 510(K)
- K873085WAYMOUTH 752/1 MEDIUM (MODIFIED) NO. 200-20851Cleared 510(K)
- K873013MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA)1Cleared 510(K)
- K873022ISCOVE'S MODIFIED DULBECCO'S MEDIUM (IMDM)1Cleared 510(K)
- K873021L-15 MEDIUM, CAT. #200-20201Cleared 510(K)
- K873019MINIMUM ESSENTIAL MEDIUM EAGLE(MEM), CAT.#200-20401Cleared 510(K)
- K873018DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)1Cleared 510(K)
- K873024MEDIUM 199, CATALOG NO. 200-20301Cleared 510(K)
- K873023RPMI-1640 W/L-GLUTAMINE AND W/O SODIUM BICARBONATE1Cleared 510(K)
- K873016MCCOY'S 5A MEDIUM (IWAKATA & GRACE MODIFICATION)1Cleared 510(K)
- K873015NUTRIENT MIXTURE F-12 (HAM), CAT. #200-20651Cleared 510(K)
- K873020MINIMUM ESSENTIAL MEDIUM EAGLE(MEM) CAT.#200-20411Cleared 510(K)
- K873014NUTRIENT MIXTURE F-10 (HAM) CAT. # 200-20601Cleared 510(K)
- K873025MINIMUM ESSENTIAL MEDIUM EAGLE(MEM) CAT.#200-21151Cleared 510(K)
- K873017DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)1Cleared 510(K)
- K873028MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA)1Cleared 510(K)
- K873027MINIMUM ESSENTIAL MEDIUM EAGLE (MEM)CAT. #200-20451Cleared 510(K)
- K873026DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)1Cleared 510(K)
- K872918GIT SERUM-FREE MEDIUM FOR CELL CULTURE1Cleared 510(K)
- K872465DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)1Cleared 510(K)
- K870451SKIN GRAFT PRESERVATION MEDIUM (TISSUE)1Cleared 510(K)
- K871250INTRA-ARTICULATED ARTHRO POWER SYSTEM1Cleared 510(K)
- K871191(DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE1Cleared 510(K)
- K870876HL-1 SUPPLEMENT1Cleared 510(K)
- K870530MEDIUM 199 WITH EARLE'S SALTS PRODUCT NO. M25201Cleared 510(K)
- K870529F-12 MEDIUM, COON'S MODIFICATION PRODUCT NO. F66361Cleared 510(K)
- K870499MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M65231Cleared 510(K)
- K870498ISCOVE MOD DULBECCO MED HYBRI-MAX, PRODUCT# I25101Cleared 510(K)
- K870497BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR1Cleared 510(K)
- K870496DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)1Cleared 510(K)
- K870495(DME) AUTO-MOD MODIFIED FOR AUTOCLAVING #D52801Cleared 510(K)
- K870494RPMI-1640 HYBRI-MAX PRODUCT NO. R80051Cleared 510(K)
- K870493NUTRIENT MIXTURE F-12 (HAM) (HEPES BUFFERED) N43881Cleared 510(K)
- K870492DULBECCO'S MODIFIED EAGLE MEDIUM BASE NO. D50301Cleared 510(K)
- K870490(DME) W/1000 MG GLUCOSE/L NO. D46551Cleared 510(K)
- K870489RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R87551Cleared 510(K)
- K870488RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R71301Cleared 510(K)
- K870487H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H90141Cleared 510(K)
- K870485LACTALBUMIN HYDROLYSATE (ELAH) NO. L37621Cleared 510(K)
- K870483WILLIAMS' MEDIUM E W/L-GLUTAMINE #W41251Cleared 510(K)
- K870481(S-MEM) AUTO-MOD PRODUCT NO. M72721Cleared 510(K)
- K870480NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE #N51381Cleared 510(K)
- K870479(DME) HYBRI-MAX W/L-GLUTAMINE PRODUCT NO. D67801Cleared 510(K)
- K870478DULBECCO'S MOD. EAGLE MED. NUT. MIX. F-12 #D29061Cleared 510(K)
- K864396LYMPHOCYTE MAINTENANCE MEDIUM1Cleared 510(K)
- K864740BONE MARROW COLLECTION MEDIUM1Cleared 510(K)
- K863696ARTHROSCOPIC SURGICAL POWER DEVICE1Cleared 510(K)
- K861996DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM1Cleared 510(K)
- K861886DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM1Cleared 510(K)
- K861887MEM GLASGOW POWDERED MEDIUM1Cleared 510(K)
- K861885WILLIAMS MEDIUM E POWDER1Cleared 510(K)
- K861871NCTC 109 MEDIUM1Cleared 510(K)
- K861875RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER1Cleared 510(K)
- K861874MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER1Cleared 510(K)
- K861873MEM GLASGOW MEDIUM1Cleared 510(K)
- K861872ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM1Cleared 510(K)
- K861870DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER1Cleared 510(K)
- K861869GENTAMICIN-50MG/ML1Cleared 510(K)
- K861868WILLIAMS MEDIUM E1Cleared 510(K)
- K861867MEM ALPHA EAGLE MEDIUM1Cleared 510(K)
- K860783MICRO CARRIER1Cleared 510(K)
- K860788HAM'S F-12 W/GLUTAMINE & NAHCO31Cleared 510(K)
- K860787DULBECCO'S MEM1Cleared 510(K)
- K860786RPMI 1640 HEPES1Cleared 510(K)
- K860785HAM'S F-12 W/NAHCO31Cleared 510(K)
- K860623CELLGRO HEPES BUFFER SOLUTION1Cleared 510(K)
- K860282RPMI 1640 W/GLUTAMINE W/HEPES1Cleared 510(K)
- K855085TISSUE CULTURE MEDIA1Cleared 510(K)
- K854567PENICILLIN/STREPTOMYCIN SOLUTION1Cleared 510(K)
- K852602MCCOY'S 5A MEDIUM-LIQUID FORM1Cleared 510(K)
- K852568MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON1Cleared 510(K)
- K852485CELLGRO(ISCOVE'S MEDIUM) MODIFICATION1Cleared 510(K)
- K852475CELLGRO WILLIAMS' MEDIUM E1Cleared 510(K)
- K852288CELLGRO1Cleared 510(K)
- K851863NCTC-135 MEDIUM N32621Cleared 510(K)
- K851862MCDB 302 MEDIUM, M20211Cleared 510(K)
- K851738MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &1Cleared 510(K)
- K851737MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &1Cleared 510(K)
- K851605SWIN'S S-77 MEDIUM, PRODUCTS S25131Cleared 510(K)
- K851609SFRE 199-2 MEDIUM, PRODUCTS NO. S21381Cleared 510(K)
- K851608SFRE199-1 MEDIUM PRODUCT NO. S 20131Cleared 510(K)
- K851607MCDB 151 MEDIUM, PRODUCT NO. M66451Cleared 510(K)
- K851606D-PBS, PRODUCTS NO. D56521Cleared 510(K)
- K851604CRCM-30 MEDIUM PRODUCT NO. C50301Cleared 510(K)
- K850886COMPRESSION HIP SCREW SYSTEM1Cleared 510(K)
- K850990HFF GENCELLS1Cleared 510(K)
- K850679TRYPSIN-EDTA SOLUTION1Cleared 510(K)
- K850922MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL1Cleared 510(K)
- K850921MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE -1Cleared 510(K)
- K850891DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT1Cleared 510(K)
- K850890MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED &1Cleared 510(K)
- K850537CELL CULTURE REFEED MEDIUM1Cleared 510(K)
- K850227HAM'S MIXTURE F-12 MEDIUM1Cleared 510(K)
- K850226MCCOY'S MEDIUM 5A, IWAKATA & GRACE MODIFICA-1Cleared 510(K)
- K850237EBSS W/O CA & MG1Cleared 510(K)
- K850236BME AMINO ACIDS 100X1Cleared 510(K)
- K850235BME VITAMINS 100X1Cleared 510(K)
- K850234H-MEM POWDERED MEDIUM1Cleared 510(K)
- K850233MEM ESSENTIAL AMINO ACIDS 50X1Cleared 510(K)
- K850232E.MEM POWDERED MEDIUM1Cleared 510(K)
- K850228HAM'S MIXTURE F-10 MEDIUM1Cleared 510(K)
- K850225FISCHER'S MEDIUM1Cleared 510(K)
- K850223EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED1Cleared 510(K)
- K850220ALPHA MEM W/O NUCLEOSIDES POWDER MEDIUM1Cleared 510(K)
- K850219MEM W/SPINNER SALTS POWDER MEDIUM1Cleared 510(K)
- K850218SWIM'S S-77 POWDER MEDIUM1Cleared 510(K)
- K850217CYNOMOLGUS MONKEY BLOOD IN ALSEVER'S1Cleared 510(K)
- K850229RPMI-1603 MEDIUM1Cleared 510(K)
- K850230RPMI-1634 MEDIUM1Cleared 510(K)
- K850222HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED-1Cleared 510(K)
- K850221ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM1Cleared 510(K)
- K850224WAYMOUTH'S MEDIUM MB 752/11Cleared 510(K)
- K850510EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN1Cleared 510(K)
- K850513RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 16401Cleared 510(K)
- K850511EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA1Cleared 510(K)
- K850520NEAA-NON-ESSENTIAL AMINO ACIDS1Cleared 510(K)
- K850519GLUTAMINE-1-GLUTAMINE1Cleared 510(K)
- K850518NA PYRUVATE-SODIUM PYRUVATE1Cleared 510(K)
- K850517MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS1Cleared 510(K)
- K850516HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM1Cleared 510(K)
- K850515HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM1Cleared 510(K)
- K850514ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID1Cleared 510(K)
- K850512DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM1Cleared 510(K)
- K850526EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION1Cleared 510(K)
- K850525DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE1Cleared 510(K)
- K850524HBSS-HANKS' BALANCED SALT SOLUTION1Cleared 510(K)
- K850523EBSS-EARLE'S BALANCE SALT SOLUTION1Cleared 510(K)
- K850522MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS1Cleared 510(K)
- K850521MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS1Cleared 510(K)
- K850089MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT1Cleared 510(K)
- K850092DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A1Cleared 510(K)
- K850090DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/1000 MG/L1Cleared 510(K)
- K850091BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE1Cleared 510(K)
- K845012NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE1Cleared 510(K)
- K845013RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO1Cleared 510(K)
- K845014MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES1Cleared 510(K)
- K844288INRA MENEZO B2 MEDIA1Cleared 510(K)
- K843863ULTRACLONE ECL-01-1300 CELL LINE1Cleared 510(K)
- K843862ULTRACLONE ECL-01-900 CELL LINE1Cleared 510(K)
- K843864ULTRACLONE ECL-01-1400 CELL LINE1Cleared 510(K)
- K843085RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA1Cleared 510(K)
- K843086DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX1Cleared 510(K)
- K842776MINIMUM ESSENTIAL MED W/L-GLUTAMINE1Cleared 510(K)
- K842775MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB1Cleared 510(K)
- K843043MED. 199 CATALOG M3769 W/EARLE'S SALT1Cleared 510(K)
- K843044MINIM. ESSENTIAL MED. EAGLE M4144 W/1Cleared 510(K)
- K843045LACTALBUMIN HYDROLYSATE MED. CATALOG1Cleared 510(K)
- K842671BASAL MED. EAGLE B8265, W/EARLS SALTS1Cleared 510(K)
- K842672MINIMUM ESSENTIAL MED. M0769 W/WO1Cleared 510(K)
- K841993HL-1, DEFINED SERUM FREE MEDIA1Cleared 510(K)
- K842002HANKS BALANCED SALTS-HBSS H23871Cleared 510(K)
- K840744TRANSPORTER VIRAL TRANSPORT MEDIUM1Cleared 510(K)
- K841744DULBECCO'S PHOSPHATE BUFFERED SALINE1Cleared 510(K)
- K834116DEAE-DEXTRAN IN PBS1Cleared 510(K)
- K834113TISSUE CULTURE REFEEDING MEDIUM1Cleared 510(K)
- K834136PBS W/MG+2 & CA+21Cleared 510(K)
- K834122CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX1Cleared 510(K)
- K833394MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE1Cleared 510(K)
- K833393ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM1Cleared 510(K)
- K833392WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE1Cleared 510(K)
- K833391LACTALBUMIN HYDROLYSATE MED. W/HANKS1Cleared 510(K)
- K833390TYRODE'S SALT SOLUTION W/SODIUM BICAR1Cleared 510(K)
- K833389MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM1Cleared 510(K)
- K833165FISHERS MED. FOR LEUKEMIC CELLS-MICE1Cleared 510(K)
- K833168MEM-EAGLE-W/EARLES SALTS W/NEAA &1Cleared 510(K)
- K833163MEM-EAGLE W/EARLES SALTS W/IVEAA1Cleared 510(K)
- K833169MEM W/L-GLUTAMINE W/O SODIUM BICARBON1Cleared 510(K)
- K833164L-15-LEIBOVITZ W/L-GLUTAMINE-L43861Cleared 510(K)
- K833016TISSUE TRANSPORT MEDIUM1Cleared 510(K)
- K832930SPINNER SALT SOLUTION S-6011 W/EARLES1Cleared 510(K)
- K832841NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM1Cleared 510(K)
- K832836BASAL MED. #B9763 W/HANKS SALTS W/L-G1Cleared 510(K)
- K832842DULBECCOS MODIFIED EAGLES MEDIUM D56481Cleared 510(K)
- K832835DULBECCOS PHOSPHATE BUFFERED SALINE1Cleared 510(K)
- K832838EARLES BALANCED SALT MIXTURE #E61321Cleared 510(K)
- K832840MINIMUM ESSENTIAL MED. EAGLE M4642 W/1Cleared 510(K)
- K832839HANKS BALANCED SALT MIXTURE H61361Cleared 510(K)
- K832837NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA1Cleared 510(K)
- K832689MCCOY'S 5A #M4892 W/L-GLUTAMINE AND1Cleared 510(K)
- K832688DULBECCO'S MODIFIED EAGLE #D5523-1Cleared 510(K)
- K832687BASAL MED. EAGLE #B9888 W/L-GLUTAMINE1Cleared 510(K)
- K832690MINIMUM ESSENTIAL MED. EAGLE M02681Cleared 510(K)
- K831686CHLAMYDIA OVERBY MEDIA1Cleared 510(K)
- K831745BASAL MEDIUM EAGLE W/EARLES SALTS, &1Cleared 510(K)
- K831685SF REFEEDING MEDIA1Cleared 510(K)
- K831519RPMI-1640 MEDIUM W/L-GLUTAMINE &1Cleared 510(K)
- K821911S-MEM-JOKLIK'S POWDER1Cleared 510(K)
- K821912MCCOY'S POWDER MEDIUM 5A SUSPENSION1Cleared 510(K)
- K821919POWDERED RPMI-1634 MEDIUM1Cleared 510(K)
- K821918POWDERED RPMI-1603 MEDIUM1Cleared 510(K)
- K821917WAYMOUTH'S POWDER MEDIUM1Cleared 510(K)
- K821916IMPROVED MEM-RICHTER'S POWDER MODIF.1Cleared 510(K)
- K821915BME AUTOCLAVABLE MEDIUM1Cleared 510(K)
- K821914COON'S F-12 POWDER MEDIUM1Cleared 510(K)
- K821913ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM1Cleared 510(K)
- K820914EMEM POWERED MEDIUM1Cleared 510(K)
- K820931HANK'S 199 POWDERED MEDIUM1Cleared 510(K)
- K820930FISCHER'S POWDERED MEDIUM1Cleared 510(K)
- K820929RPMI-164POWDERED MEDIUM1Cleared 510(K)
- K820926E-BME POWDERED MEDIUM1Cleared 510(K)
- K820925H - BME POWDERED MEDIUM1Cleared 510(K)
- K820924HAMS F-12 POWDERED MEDIUM1Cleared 510(K)
- K820922HAMS F-10 POWDERED MEDIUM1Cleared 510(K)
- K820921D-MEM-LOW GLUCOSE-POWDERED MEDIUM1Cleared 510(K)
- K820920MCCOY'S 5A POWDERED MEDIUM1Cleared 510(K)
- K820919EARLE'S-199 POWDERED MEDIUM1Cleared 510(K)
- K820918HMEM POWDERED MEDIUM1Cleared 510(K)
- K820917L-15 POWDERED MEDIUM1Cleared 510(K)
- K820916D-MEM-HIGH GLUCOSE-POWDERED MEDIUM1Cleared 510(K)
- K820915MEM AUTOCLAVABLE MEDIUM1Cleared 510(K)
- K820509MEM VITAMINS (100X1Cleared 510(K)
- K820495SODIUM PYRUVATE (100MM)1Cleared 510(K)
- K820508MEM NON-ESSENTIAL AMINO ACIDS (100X)1Cleared 510(K)
- K812885DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM1Cleared 510(K)
- K812820CHANG MEDIUM1Cleared 510(K)
- K812531CELL CULTURE REAGENTS1Cleared 510(K)
- K812617VITROGEN TM 1001Cleared 510(K)
- K810783ALSEVER'S SOLUTION (MODIFIED)1Cleared 510(K)
- K810768MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS1Cleared 510(K)
- K810769MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE1Cleared 510(K)
- K810770MED. 199(MODIFIED) W/HANKS' SALTS1Cleared 510(K)
- K810771L-15 MEDIUM (MODIFIED)1Cleared 510(K)
- K810772MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE1Cleared 510(K)
- K810773BASAL MEDIUM EAGLE W/HANKS' SALTS1Cleared 510(K)
- K810774WATER-TISSUE CULTURE GRADE1Cleared 510(K)
- K810776PENICILLIN-STREPTOMYCIN MIXTURE1Cleared 510(K)
- K810778BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT1Cleared 510(K)
- K810780SODIUM BICARBONATE (7.5%) SOLUTION1Cleared 510(K)
- K810781L-GLUTAMINE1Cleared 510(K)
- K810767RPMI 1640 MEDIUM1Cleared 510(K)
- K810784FUNGIZONE1Cleared 510(K)
- K803041SERUM FREE TISSUE CULTURE MEDIA1Cleared 510(K)
- K770764TISSUE CULTURE MEDIA W/HEPES BUFFER1Cleared 510(K)
- KIWKit, Mycoplasma Detection1Product Code
- KIXMedia, Mycoplasma Detection1Product Code
- KIYChamber, Slide Culture1Product Code
- KIZDish, Tissue Culture1Product Code
- KJAFlask, Tissue Culture1Product Code
- KJBApparatus, Roller1Product Code
- KJCBottle, Roller, Tissue Culture1Product Code
- KJDSpinner, Flask1Product Code
- KJESpinner System, Cell Culture1Product Code
- KJFSystem, Suspension, Cell Culture1Product Code
- KJHApparatus, Perfusion1Product Code
- KPBMedia And Components, Mycoplasma Detection1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K845013
- 510(k) Type
- Traditional
- Applicant
- SIGMA CHEMICAL CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/27/1985
- Days to Decision
- 63 days