Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- FLKThermometer, Clinical Mercury2Product Code
- CARMonitor, Spinal-Fluid Pressure, Electrically Powered2Product Code
- FLLThermometer, Electronic, Clinical2Product Code
- FLNMonitor, Electric For Gravity Flow Infusion Systems2Product Code
- FMJManometer, Spinal-Fluid2Product Code
- FQAScale, Surgical Sponge1Product Code
- FQZThermometer, Clinical Color Change1Product Code
- FRCIndicator, Biological Sterilization Process2Product Code
- K250061Celerity Incubator2Cleared 510(K)
- K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)2Cleared 510(K)
- K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M2Cleared 510(K)
- K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)2Cleared 510(K)
- K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M2Cleared 510(K)
- K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)2Cleared 510(K)
- K231383Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)2Cleared 510(K)
- K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M2Cleared 510(K)
- K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)2Cleared 510(K)
- K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E2Cleared 510(K)
- K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)2Cleared 510(K)
- K233681ConFirm 20 Minute Incubator2Cleared 510(K)
- K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator2Cleared 510(K)
- K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack2Cleared 510(K)
- K223715Celerity Incubator2Cleared 510(K)
- K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2Cleared 510(K)
- K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)2Cleared 510(K)
- K213881Celerity Incubator2Cleared 510(K)
- K2117053M Attest Rapid Readout Biological Indicator, 12952Cleared 510(K)
- K213296Anprolene SteriTest RRBI2Cleared 510(K)
- K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader2Cleared 510(K)
- K220473CELERITY 20 HP Challenge Pack2Cleared 510(K)
- K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2Cleared 510(K)
- K203560STERIZONE VP4 Test Pack2Cleared 510(K)
- K2102773M Attest Rapid Readout Biological Indicator, 12952Cleared 510(K)
- K202879EOGas 4 Endo-SteriTest RRBI2Cleared 510(K)
- K202721Celerity 20 Steam Biological Indicator for IUSS2Cleared 510(K)
- K200970Self-Contained Biological Indicator2Cleared 510(K)
- K2009963M Attest Rapid Readout Biological Indicator2Cleared 510(K)
- K192980EOGas 4 Endo-SteriTest2Cleared 510(K)
- K2007663M Attest Steam Chemical Integrator Test Pack2Cleared 510(K)
- K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H2Cleared 510(K)
- K2005363MTM AttestTM Rapid 5 Steam-Plus Test Pack2Cleared 510(K)
- K200126VERIFY Assert Self-Contained Biological Indicator2Cleared 510(K)
- K2000923MTM AttestTM Mini Auto-reader 490M2Cleared 510(K)
- K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack2Cleared 510(K)
- K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader2Cleared 510(K)
- K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device2Cleared 510(K)
- K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye2Cleared 510(K)
- K190297Celerity HP Incubator2Cleared 510(K)
- K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack2Cleared 510(K)
- K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack2Cleared 510(K)
- K182404STERRAD VELOCITY Biological Indicator2Cleared 510(K)
- K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag2Cleared 510(K)
- K181434SporView Rapid Read Biological Indicator SteamPlus Test Pack2Cleared 510(K)
- K181686CELERITY 20 Steam Biological Indicator2Cleared 510(K)
- K181429CELERITY 20 HP Biological Indicator2Cleared 510(K)
- K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader2Cleared 510(K)
- K1734373M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H2Cleared 510(K)
- K173488CELERITY 20 HP Challenge Pack2Cleared 510(K)
- K173633VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag2Cleared 510(K)
- K173629CELERITY 20 Steam Process Challenge Device for Gravity Cycles2Cleared 510(K)
- K173626Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles2Cleared 510(K)
- K173670CELERITY 20 Steam Incubator2Cleared 510(K)
- K173634CELERITY 20 Steam Biological Indicator2Cleared 510(K)
- K1734353M Attest Rapid Readout Biological Indicator2Cleared 510(K)
- K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack2Cleared 510(K)
- K172752CELERITY 20 HP Biological Indicator2Cleared 510(K)
- K171287Sporview VH202 BI2Cleared 510(K)
- K1735843M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader2Cleared 510(K)
- K172474Celerity 20 HP Biological Indicator2Cleared 510(K)
- K172432SporView Rapid Read Biological Indicator2Cleared 510(K)
- K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator2Cleared 510(K)
- K170427Anprolene SteriTest2Cleared 510(K)
- K171587VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator2Cleared 510(K)
- K171504VERIFY Assert VH2O2 Self-Contained Biological Indicator2Cleared 510(K)
- K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader2Cleared 510(K)
- K170039STERRAD VELOCITY Biological Indictator and Reader2Cleared 510(K)
- K170070VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles2Cleared 510(K)
- K163144gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)2Cleared 510(K)
- K1605463M Attest Rapid Readout Biological Indicator2Cleared 510(K)
- K151482BCR-30-min BI™ and RBIP-ST30™ Readout Accessory2Cleared 510(K)
- K1520603M Attest Rapid Readout Biological Indicator 12952Cleared 510(K)
- K151585Andersen EOGas 4 SteriTest2Cleared 510(K)
- K151971STERRAD CYCLESURE 24 Biological Indicator2Cleared 510(K)
- K141580STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K140589STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR2Cleared 510(K)
- K141238STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K141312STERILUCENT PROCESS CHALLENGE DEVICE2Cleared 510(K)
- K141244NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)2Cleared 510(K)
- K133549STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR2Cleared 510(K)
- K133322STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR2Cleared 510(K)
- K1403923M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER2Cleared 510(K)
- K140620SPORVIEW PLUS BI TEST PACK2Cleared 510(K)
- K140499VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES2Cleared 510(K)
- K140708VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K130263STERRAD 50/100S/200 TEST PACK2Cleared 510(K)
- K133267DANA REUSABLE TEST PACK2Cleared 510(K)
- K122024SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K122362SMART-WELL INCUBATOR2Cleared 510(K)
- K1235463M ATTEST(TM) AUTO-READER2Cleared 510(K)
- K1215933M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK2Cleared 510(K)
- K123017STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 143242Cleared 510(K)
- K1214843M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER2Cleared 510(K)
- K122044STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR2Cleared 510(K)
- K111391STERRAD (R) 100NX DUO CYCLE TEST PACK2Cleared 510(K)
- K111375STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR2Cleared 510(K)
- K113221NAMSA BIOLOGICAL INDICATOR SPORE STRIPS2Cleared 510(K)
- K111515SPSMEDICAL SPORVIEW STEAM BI2Cleared 510(K)
- K112018SMART READ EZTEST STEAM2Cleared 510(K)
- K113302NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS2Cleared 510(K)
- K111150STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR2Cleared 510(K)
- K1032773M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER2Cleared 510(K)
- K103222STERRAD CYCLESURE BIOLOGICAL INDICATOR2Cleared 510(K)
- K092755STERRAAD 100NX EXPRESS CYCLE TEST PACK2Cleared 510(K)
- K103321DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES2Cleared 510(K)
- K102884STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR2Cleared 510(K)
- K1019103M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS2Cleared 510(K)
- K093794SMART-READ EZTEST-STEAM SCBI AND TEST PACK2Cleared 510(K)
- K092944DANA REUSABLE TEST PACK FOR STEAM STERILIZATION2Cleared 510(K)
- K091950SMART-WELL EZTEST INCUBATOR2Cleared 510(K)
- K092906VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION2Cleared 510(K)
- K082756RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR2Cleared 510(K)
- K083665VERIFY SCBI 275F 3-102Cleared 510(K)
- K090569MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 12922Cleared 510(K)
- K090514VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES2Cleared 510(K)
- K073618VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK2Cleared 510(K)
- K073244VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES2Cleared 510(K)
- K071537STERRAD 100NX TEST PACK2Cleared 510(K)
- K071014MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR2Cleared 510(K)
- K070595SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K051056VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K051643STERRAD STERILIZER CYCLESURE TEST PACK2Cleared 510(K)
- K0521283M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER2Cleared 510(K)
- K051173SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK2Cleared 510(K)
- K042450STERRAD NX CHALLENGE PACK2Cleared 510(K)
- K050664SPOR-TEST PA BIOLOGICAL INDICATOR KIT2Cleared 510(K)
- K050591MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS2Cleared 510(K)
- K041784RAVEN PROTEST - EO2Cleared 510(K)
- K041386RAVEN PROTEST - STEAM2Cleared 510(K)
- K032914MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS2Cleared 510(K)
- K041099MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP2Cleared 510(K)
- K031012ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK2Cleared 510(K)
- K032723BIOSIGN STEAM-24 BIOLOGICAL INDICATOR2Cleared 510(K)
- K031226STERRAD CYCLESURE BIOLOGICAL INDICATOR2Cleared 510(K)
- K024079ALIBI BIOLOGICAL INDICATOR, MODEL WS2Cleared 510(K)
- K023716SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP2Cleared 510(K)
- K022706SPSMEDICAL SPORVIEW STEAM BI TEST PACK2Cleared 510(K)
- K020205CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT2Cleared 510(K)
- K0040093M ATTEST 290 AUTO-READER2Cleared 510(K)
- K994055STERRAD CYCLESURE BIOLOGICAL INDICATOR2Cleared 510(K)
- K020026RAVEN BACTERIAL SPORE STRIPS2Cleared 510(K)
- K994381PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K991618BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR2Cleared 510(K)
- K993775STERRAD BI TEST PACK2Cleared 510(K)
- K991675MODIFICATION OF: STERRAD BI TEST PACK2Cleared 510(K)
- K981497STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS2Cleared 510(K)
- K972747BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)2Cleared 510(K)
- K971430PROSPORE II2Cleared 510(K)
- K971432PROSPORE2Cleared 510(K)
- K930683EZTEST-GAS2Cleared 510(K)
- K963841EZTEST2Cleared 510(K)
- K962441PROSPORE(STEARO FOR STEAM STERILIZER)2Cleared 510(K)
- K961721STERITEC DISPOSABLE BIOLOGICAL TEST PACK2Cleared 510(K)
- K960790PROSPORE II2Cleared 510(K)
- K960777MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR2Cleared 510(K)
- K926364ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X2Cleared 510(K)
- K923739ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR2Cleared 510(K)
- K930682EZTEST-STEAM2Cleared 510(K)
- K925745ATI(R) DISP BIOLOGICAL-PLUS TEST PACK2Cleared 510(K)
- K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK2Cleared 510(K)
- K921909STERRAD BI TEST PACK2Cleared 510(K)
- K922212MDT CASTLE BIOSIGN TEST PACK2Cleared 510(K)
- K912796SPORE STRIP2Cleared 510(K)
- K905425SPORVIEW2Cleared 510(K)
- K910417EVIDENCE BIOLOGICAL INDICATOR2Cleared 510(K)
- K903024BI-O.K. STEAM TEST-PAK2Cleared 510(K)
- K902344ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER2Cleared 510(K)
- K900771ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR2Cleared 510(K)
- K895704ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE2Cleared 510(K)
- K891784BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR2Cleared 510(K)
- K890754SPORVIEW CULTURE MEDIA2Cleared 510(K)
- K894399STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.2Cleared 510(K)
- K894398STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE2Cleared 510(K)
- K891366BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)2Cleared 510(K)
- K884615ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK2Cleared 510(K)
- K884767ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK2Cleared 510(K)
- K872867BIOSIGN2Cleared 510(K)
- K863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.2Cleared 510(K)
- K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR2Cleared 510(K)
- K855120ATI DISPOSABLE BIOLOGICAL TEST PACK2Cleared 510(K)
- K854631ASSERT EO BIOLOGICAL TEST PACK2Cleared 510(K)
- K854902SURGICOT STEAM TEST PACK2Cleared 510(K)
- K844479CHEMSPOR2Cleared 510(K)
- K852192DISPOSABLE STEAM BIOLOGICAL TEST PACK2Cleared 510(K)
- K850144BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH2Cleared 510(K)
- K84170948 HOUR BIOLOGICAL INDICATORS SPORSTRIP2Cleared 510(K)
- K841583SPORSTRIP2Cleared 510(K)
- K832922TRAVASPORE BIOLOGICAL INDICATOR2Cleared 510(K)
- K822024BACILLU S SUBTILIS BIOLOGICAL INDICA.2Cleared 510(K)
- K812272CASTLE TEC-TEST BIOLOGICAL INDICATOR2Cleared 510(K)
- K810930BACILLUM PUMILUS SPORE STRIPS2Cleared 510(K)
- K802228BIOLOGICAL INDICATOR - KEMMED & BIOSURE2Cleared 510(K)
- K801678SPOR-TEST-STRIP2Cleared 510(K)
- K800482STEAROTHERMOHILUS SPORE STRIPS2Cleared 510(K)
- K800029SURGICOT 2 INDICATOR SYSTEM2Cleared 510(K)
- K792648UNILAB CULTURING SET2Cleared 510(K)
- K792649UNISPORE-BIOLOGICAL INDICATORS2Cleared 510(K)
- K771132KENWOOD BIOLOGICAL STEOILIZ. INDICATOR2Cleared 510(K)
- K771080STEAM STERILIZATION INDICATOR2Cleared 510(K)
- K770953MONITOR, AERATION, TEC-TEST2Cleared 510(K)
- K761015MARKET CASTLE UNISPHERE2Cleared 510(K)
- FRIScale, Stand-On, Patient1Product Code
- FRWScale, Patient1Product Code
- JOJIndicator, Physical/Chemical Sterilization Process2Product Code
- KMIMonitor, Bed Patient1Product Code
- KPDStrip, Temperature, Forehead, Liquid Crystal2Product Code
- LHBTimer, Apgar1Product Code
- LRTIndicator, Sterilization2Product Code
- MRBIndicator, Biological, Liquid Chemical Sterilization Process2Product Code
- MRLScale, Sponge, Surgical, Electrically-Powered1Product Code
- MTCIndicator, Chemical, Enzymatic, Sterilization Process2Product Code
- OCIIndicator, Physical/Chemical, Storage Temperature2Product Code
- OZKThermometer, Exhaled Breath2Product Code
- PJOFall Prevention Alarm/Sensor Combination Attached Or Unattached1Product Code
- PJPFall Prevention Alarm/Sensor Attached Only1Product Code
- PWWFever Monitoring Kit2Product Code
- PXHThermometer Kit2Product Code
- QKMA Chemical Vapor Sterilization Multivariable Chemical Indicator2Product Code
- SBOBed-Patient Activity Monitoring System1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212193
- 510(k) Type
- Traditional
- Applicant
- Plasmapp Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/22/2021
- Days to Decision
- 100 days
- Submission Type
- Summary