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
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- GMBLight, Wood'S, Fluorescence1Product Code
- GTLPhages, Staphylococcal Typing, All Types1Product Code
- JRZMedia, Culture, Amino Acid Assay1Product Code
- JSACulture Media, Antibiotic Assay1Product Code
- JSBCulture Media, Vitamin Assay1Product Code
- JSCCulture Media, General Nutrient Broth1Product Code
- JSDCulture Media, Selective Broth1Product Code
- JSECulture Media, Multiple Biochemical Test1Product Code
- JSFCulture Media, Single Biochemical Test1Product Code
- JSGCulture Media, Non-Selective And Non-Differential1Product Code
- JSHCulture Media, Non-Selective And Differential1Product Code
- JSICulture Media, Selective And Differential1Product Code
- JSJCulture Media, Selective And Non-Differential1Product Code
- JSKSupplement, Culture Media1Product Code
- JSLCulture Media, Anaerobic Transport1Product Code
- JSMCulture Media, Non-Propagating Transport1Product Code
- JSNCulture Media, Propagating Transport1Product Code
- JSPKit, Anaerobic Identification1Product Code
- JSRKit, Identification, Dermatophyte1Product Code
- JSSKit, Identification, Enterobacteriaceae1Product Code
- JSTKit, Fastidious Organisms1Product Code
- JSWKit, Identification, Glucose Nonfermenter1Product Code
- JSXKit, Identification, Neisseria Gonorrhoeae1Product Code
- JSYKit, Identification, Mycobacteria1Product Code
- JSZKit, Identification, Pseudomonas1Product Code
- JTAMonitor, Microbial Growth1Product Code
- JTBDevice, Media Dispensing/Stacking1Product Code
- JTCDevice, Microtiter Diluting/Dispensing1Product Code
- JTLPlasma, Coagulase, Human, Horse And Rabbit1Product Code
- JTMAnaerobic Box Glove1Product Code
- JTODiscs, Strips And Reagents, Microorganism Differentiation1Product Code
- K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT1Cleared 510(K)
- K970832PYR SWAB1Cleared 510(K)
- K970834GRAM SWAB1Cleared 510(K)
- K970833INDOLE SWAB1Cleared 510(K)
- K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACIN1Cleared 510(K)
- K962966IDS RAPID CB PLUS SYSTEM1Cleared 510(K)
- K961191COLISCREEN1Cleared 510(K)
- K960996M. CAT BUTYRATE DISK1Cleared 510(K)
- K955826GIBSON ID-M. CAT.1Cleared 510(K)
- K954783DRYSLIDE CARTARRHALIS1Cleared 510(K)
- K954812LYFO(TM) DIFFERIENTAL DISK-PYR1Cleared 510(K)
- K953247GIBSON ID A.E. TEST1Cleared 510(K)
- K951889LYFO(TM) DIFFERENTIAL DISK1Cleared 510(K)
- K950346B-L RED(TM) DISCS1Cleared 510(K)
- K945881LYFO(TM) DIFFERENTIAL DISK-STERILE DISK1Cleared 510(K)
- K945883LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN1Cleared 510(K)
- K945882LYFO(TM) DIFFERENTIAL DISK-BILE1Cleared 510(K)
- K945880LYFO(TM) DIFFERENTIAL DISK-SPS1Cleared 510(K)
- K934130SWABZYME OXIDASE1Cleared 510(K)
- K940162GONOCHEK II REAGENT TUBES1Cleared 510(K)
- K940161B-LACTAMASE REAGENT TUBES1Cleared 510(K)
- K934125GONOCHEK-II, MODIFICATION1Cleared 510(K)
- K940124EY-20 REAGENT TUBES1Cleared 510(K)
- K940020STREP-A-CHEK(TM) REAGENT STRIPS1Cleared 510(K)
- K934129STREP-A-CHEK1Cleared 510(K)
- K941111STREP-SURE A/E1Cleared 510(K)
- K941016DISPENS-O-DISC(TM) NITROCEFIN1Cleared 510(K)
- K936021BACTICARD STREP1Cleared 510(K)
- K936034SERIM PYLORITEK REAGENT STRIPS1Cleared 510(K)
- K934986BACTICARD E. COLI1Cleared 510(K)
- K931865PYR TEST KIT1Cleared 510(K)
- K932752VISI-SPOT1Cleared 510(K)
- K933514BACTICARD STREP1Cleared 510(K)
- K931862NINHYDRIN REAGENT1Cleared 510(K)
- K931414CATALASE REAGENT1Cleared 510(K)
- K930693OXYSTRIP1Cleared 510(K)
- K930878BACTIDROP(TM) MUCAP1Cleared 510(K)
- K931413FERRIC CHLORID REAGENT, 10%1Cleared 510(K)
- K930720VOGUES-PROSKAUER REAGENT A & B1Cleared 510(K)
- K930718INDOLE SPOT & INDOLE KOVACS REAGENT1Cleared 510(K)
- K930717NITRATE REAGENTS A, B AND C1Cleared 510(K)
- K926254BBL PYR REAGENT DROPPERS1Cleared 510(K)
- K926256BBL NINHYDRIN REAGENT DROPPERS1Cleared 510(K)
- K926255BBL NITRATE A, B REAGENT DROPPERS1Cleared 510(K)
- K925747DRYSLIDE(TM) INDOLE1Cleared 510(K)
- K923700INDOXYL ACETATE DISK1Cleared 510(K)
- K923827LAP DISK1Cleared 510(K)
- K921583DRYSLIDE(TM), PYR1Cleared 510(K)
- K920973BACTIDROP INDOLE (ERLICH'S)1Cleared 510(K)
- K920971BACTIDROP NINHYDRIN1Cleared 510(K)
- K920972BACTIDROP PYR1Cleared 510(K)
- K920257NIACIN CONTROL DISKS1Cleared 510(K)
- K913008BACTIDROP(TM) OXIDASE1Cleared 510(K)
- K913002BACTIDROP(TM) FERRIC CHLORIDE (10%)1Cleared 510(K)
- K913003BACTIDROP(TM) VOGES-PROSKAUER A1Cleared 510(K)
- K913006BACTIDROP(TM) DOBELL & O'CONNOR IODINE1Cleared 510(K)
- K913007BACTIDROP(TM) VOGES-PROSKAUER B1Cleared 510(K)
- K913010BACTIDROP (TM) NITRATE B1Cleared 510(K)
- K913011BACTIDROP(TM) NITRATE A1Cleared 510(K)
- K913009BACTIDROP(TM) INDOLE (KOVACS)1Cleared 510(K)
- K913004BACTIDROP(TM) SPOT INDOLE1Cleared 510(K)
- K913001BACTIDROP(TM) DESOXYCHOLATE (10%)1Cleared 510(K)
- K912480BBL(R) DMACA INDOLE REAGENT DROPPERS1Cleared 510(K)
- K905472LAP DISCS1Cleared 510(K)
- K905666M. CAT. BUTYRATE DISC1Cleared 510(K)
- K905163NITRATE DISK1Cleared 510(K)
- K905151VANCOMYCIN DISK-5 MCG1Cleared 510(K)
- K902595CATARRHALIS TEST STRIP1Cleared 510(K)
- K902640DMAC INDOLE REAGENT1Cleared 510(K)
- K901784DRYSLIDE, BETA-LACTAMASE1Cleared 510(K)
- K902037PATHODX PYR KIT1Cleared 510(K)
- K901390DMAC INDOLE REAGENT1Cleared 510(K)
- K896398DIFCO OXIDASE DRYSLIDE1Cleared 510(K)
- K894221ROSCO PYRR1Cleared 510(K)
- K890625JAMES REAGENT1Cleared 510(K)
- K882630PRO DISCS1Cleared 510(K)
- K882636ALN DISCS1Cleared 510(K)
- K880694B. CAT CONFIRM1Cleared 510(K)
- K880950PYR/ESCULIN DISK1Cleared 510(K)
- K874933MUG-INDOLE DISC1Cleared 510(K)
- K873509IDENTICULT-BL1Cleared 510(K)
- K873034CONTROLCHEK II(TM)1Cleared 510(K)
- K871907LD PRESUMPTO QUAD1Cleared 510(K)
- K871445CONTROLCHEK(TM)1Cleared 510(K)
- K870561CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION1Cleared 510(K)
- K870410CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS1Cleared 510(K)
- K870422GEN-PROBE BETA-LACTAMASE TEST KIT1Cleared 510(K)
- K870409CHROMAGEN TEST FOR GROUP A STREP1Cleared 510(K)
- K870716SPOTTEST 10% SODIUM DESOXYCHOLATE1Cleared 510(K)
- K870717SPOTTEST MICRODASE1Cleared 510(K)
- K864244GARNERELLA VAGINALIS IDENTIFICATION KIT1Cleared 510(K)
- K870449SPOTTEST PYR REAGENT1Cleared 510(K)
- K863601ONPG SOLUTION1Cleared 510(K)
- K863216NEIS NZY1Cleared 510(K)
- K862570DISPENS-O-DISC DIFFERENTIATION DISKS PYR1Cleared 510(K)
- K861888HIPPURATE HYDROLYSIS TEST1Cleared 510(K)
- K861889D'ALA RAPID TEST1Cleared 510(K)
- K861058SENSITITRE AUTO ID PLATE, AP701Cleared 510(K)
- K861259MACCONKEY W/MUG1Cleared 510(K)
- K860564DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG1Cleared 510(K)
- K860561DIFFERENTIATION DISKS PENICILLIN G 2 UNITS1Cleared 510(K)
- K860562DIFFERENTIATION DISKS COLISTIN 10 MCG1Cleared 510(K)
- K860565DIFFERENTIATION DISKS KANAMYCIN 1000 MCG1Cleared 510(K)
- K860563DIFFERENTIATION DISKS VANCOMYCIN 5 MCG1Cleared 510(K)
- K860560DIFFERENTIATION DISKS RIFAMPIN 15 MCG1Cleared 510(K)
- K860156NEISSERIASTAT1Cleared 510(K)
- K860396BIOTIS NUTRIENT GELATIN1Cleared 510(K)
- K860301RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE1Cleared 510(K)
- K860302PYR DISCS1Cleared 510(K)
- K860091BIO SPEC GRAMAFLUOR TEST KIT1Cleared 510(K)
- K854448AUTOSCAN W/A SYSTEM1Cleared 510(K)
- K852886MUG DISK1Cleared 510(K)
- K852889GENERAL DIAGNOSTICS RAPID E. COLI TEST1Cleared 510(K)
- K852832IDENTICULT-NEISSERIA1Cleared 510(K)
- K852666IDENTICULT-AE1Cleared 510(K)
- K851184SPOTTEST INDIA INK1Cleared 510(K)
- K844887IDENTIFICATION STICKS OXIDASE1Cleared 510(K)
- K844380BILE DIFFERENTIAL DISK1Cleared 510(K)
- K844383KANAMYCIN 1000 MCG DIFFERENTIAL DISK1Cleared 510(K)
- K844382VANCOMYCIN 5MCG DIFFERENTIAL DISK1Cleared 510(K)
- K844381COLISTIN 10 MCG. DIFFERENTIAL DISK1Cleared 510(K)
- K844276E-COLI-CHEK TUBE1Cleared 510(K)
- K844020PYRIDOXAL DISC1Cleared 510(K)
- K844086POS COMBO PANEL1Cleared 510(K)
- K844019STREP ID TRIPLATE1Cleared 510(K)
- K843987PYR BROTH1Cleared 510(K)
- K843521DIFFERENTIATION DISKS NITRATE1Cleared 510(K)
- K843316INDOLE SPOT TEST KIT 270-251Cleared 510(K)
- K842828STREPTEX ZL011Cleared 510(K)
- K842587GNC PLUS1Cleared 510(K)
- K842086SPOTTEST LACTOPHENOL COTTON BLUE STAIN1Cleared 510(K)
- K841453DIFFERENTIATION DISKS SPECTINOMYCIN1Cleared 510(K)
- K841460RIM GARDNERELLA VAGINALIS KIT1Cleared 510(K)
- K841329RIM ONPG KIT1Cleared 510(K)
- K841479BIO SPEC STREP-A-FLUOR TEST KIT1Cleared 510(K)
- K841508RIM 6.5% NACL1Cleared 510(K)
- K841277RIM-HIPPURATE1Cleared 510(K)
- K841270RIM - NITRATE TEST1Cleared 510(K)
- K841262RIM-BILE ESCULIN TEST1Cleared 510(K)
- K840708COLISTIN DISC1Cleared 510(K)
- K8406862U PENICILLIN DISC1Cleared 510(K)
- K840614RIFAMPIN DISC1Cleared 510(K)
- K840810SWABZYME-OXIDASE1Cleared 510(K)
- K840896DIFFERENTIATION DISKS ALA1Cleared 510(K)
- K840884STREP-A-CHEK TUBE1Cleared 510(K)
- K840804DIFFERENTIATION DISKS SPS1Cleared 510(K)
- K840819MICRODASE1Cleared 510(K)
- K840508NEISSERIA MENINGITIDIS GR. C1Cleared 510(K)
- K834389AMS GRAM-POSITIVE IDENT. CARD1Cleared 510(K)
- K834269AMS GRAM-NEGATIVE IDENT. CARD1Cleared 510(K)
- K840584SPOTTEST ACRIDINE ORANGE STAIN1Cleared 510(K)
- K840483NOVOBIOCIN DISC1Cleared 510(K)
- K840031MICROBIAL DIFFERENTIATION1Cleared 510(K)
- K840030REAGENTS1Cleared 510(K)
- K840029STRIPS1Cleared 510(K)
- K840028DISCS1Cleared 510(K)
- K840575SPOTTEST OXIDASE REAGENT1Cleared 510(K)
- K840582SPOTTEST FERRIC CHLORIDE REAGENT1Cleared 510(K)
- K840583SPOTTEST VOGES-PROSKAUER REAGENT B1Cleared 510(K)
- K840581SPOTTEST NITRATE REAGENT C1Cleared 510(K)
- K840580SPOTTEST NITRATE REAGENT B1Cleared 510(K)
- K840579SPOTTEST NITRATE REAGENT A1Cleared 510(K)
- K840578SPOTTEST VOGES-PROSKAUER REAGENT A1Cleared 510(K)
- K840577SPOTTEST KOVACS' INDOLE REAGENT1Cleared 510(K)
- K840576SPOTTEST DMACA INDOLE REAGENT1Cleared 510(K)
- K840252RIM GRAM REACTION SWAB1Cleared 510(K)
- K834581DIFFERENTIATION DISKS HIPPURATE1Cleared 510(K)
- K833654IDS RAPID STR SYSTEM1Cleared 510(K)
- K834029BIO-UREA1Cleared 510(K)
- K834028BIO-ORNITHINE1Cleared 510(K)
- K834022PVP IODINE1Cleared 510(K)
- K833963HAEMOPHILUS IDENTIFICATION TEST KIT1Cleared 510(K)
- K833407SELECTO-DISC NOVOBIOCIN 5UG1Cleared 510(K)
- K833901BACTROL GRAM SLIDE1Cleared 510(K)
- K832587RIME COLI KIT1Cleared 510(K)
- K832436SELECTRO-DISC1Cleared 510(K)
- K832307ONPG DISCS1Cleared 510(K)
- K832305SPS DISCS1Cleared 510(K)
- K832306BILE AESCULIN DISCS1Cleared 510(K)
- K830756GONOCHEK PANEL1Cleared 510(K)
- K831674RIM-CAMP TEST1Cleared 510(K)
- K831673OXY-SWAB1Cleared 510(K)
- K831654RIM BETA LACTAMASE TEST1Cleared 510(K)
- K830968RAPID IDENTIFI-METHOD NEISSERIA KIT1Cleared 510(K)
- K831187TRP1Cleared 510(K)
- K830939THYMINE/THYMIDINE DISCS DDG1Cleared 510(K)
- K830323LYSOSTAPHIN REAGENT SET1Cleared 510(K)
- K830099MS-2 BACTERIAL IDENTI. SYS1Cleared 510(K)
- K823718SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP1Cleared 510(K)
- K823738GRAM NEGATIVE BACTERIAL IDENTIF- PANELS1Cleared 510(K)
- K823198RAPID PRESUMPTIVE IDENT. GPA STREP1Cleared 510(K)
- K822946BACTEC NAP TB DIFFERENTIATION TEST1Cleared 510(K)
- K822930CSM CHROMOGENIC B-LACTAMASE DISC1Cleared 510(K)
- K821992ALPHA-TOXIN DISCS1Cleared 510(K)
- K821907NEIDENT*1Cleared 510(K)
- K821040RAPID SST1Cleared 510(K)
- K820264AMS GRAM-POSITIVE IDENTIFICATION CARD1Cleared 510(K)
- K813613RAPID CH1Cleared 510(K)
- K813612RAPID ZYME1Cleared 510(K)
- K820211NINHYDRIN1Cleared 510(K)
- K820209ZYME B1Cleared 510(K)
- K820210IND1Cleared 510(K)
- K820212OXI1Cleared 510(K)
- K820213SALINE SOLUTION1Cleared 510(K)
- K820207NIT 21Cleared 510(K)
- K820206NIT 11Cleared 510(K)
- K820205VP 21Cleared 510(K)
- K820204VP I1Cleared 510(K)
- K813610RAPID STREP1Cleared 510(K)
- K813509METRONIDAZOLE DIAGNOSTIC DISCS1Cleared 510(K)
- K813442CEFINASE TM DISCS1Cleared 510(K)
- K813031MS-2 BACTERIAL IDENTIFICATION SYS1Cleared 510(K)
- K812877PENASE1Cleared 510(K)
- K812862API GERM TUBE1Cleared 510(K)
- K812859IDS PORPHYRIN REAGENT1Cleared 510(K)
- K812458PADAC1Cleared 510(K)
- K812084SPS DISK1Cleared 510(K)
- K812083BILE DISK1Cleared 510(K)
- K812082KANAMYCIN DISK1Cleared 510(K)
- K812047IDS BETA-LACTAMASE DISC1Cleared 510(K)
- K811998STAPH-IDENT1Cleared 510(K)
- K811854GALACTOSID-ASE TUBES1Cleared 510(K)
- K811853PHOLPHORYL-ASE TUBES1Cleared 510(K)
- K810541BETA LYSIN DISK1Cleared 510(K)
- K802509G.R.A.M. SLIDE1Cleared 510(K)
- K802502X & V FACTOR DISCS1Cleared 510(K)
- K802497BACTIRACIN DIAGNOSTIC DISC1Cleared 510(K)
- K802496OPTOCHIN DIAGNOSTIC DISC1Cleared 510(K)
- K802501V FACTOR DISCS1Cleared 510(K)
- K802500X-FACTOR DISCS1Cleared 510(K)
- K802566BETA LACTAMASE REAGENT DISK1Cleared 510(K)
- K801951API-CTS STREPTOCOCCUS1Cleared 510(K)
- K802127BACITRACIN DIFFERENTIATION DISC1Cleared 510(K)
- K801916ORNITH-ASE TUBES1Cleared 510(K)
- K801915ENZYME-ASE I TUBES1Cleared 510(K)
- K801493ALA SWAB1Cleared 510(K)
- K801492PORPHYRIN (ALA) DISK1Cleared 510(K)
- K800816HIPPUR-ASE TUBES1Cleared 510(K)
- K800579BETA-ASE TUBES1Cleared 510(K)
- K782086AM-PEN SCREEN1Cleared 510(K)
- K790038DISK, BETA-LACTAM1Cleared 510(K)
- K781567API ZYM1Cleared 510(K)
- K770926SUSPENSION SALINE, API 20E1Cleared 510(K)
- K761209TAXO DISCS FOR DIFF. OF ANAEROBES1Cleared 510(K)
- JTQBath, Incubators/Water, All1Product Code
- JTRKit, Quality Control For Culture Media1Product Code
- JTWSystem, Transport, Aerobic1Product Code
- JTXTransport Systems, Anaerobic1Product Code
- JTYCulture Media, For Isolation Of Pathogenic Neisseria2Product Code
- JWXKit, Screening, Staphylococcus Aureus1Product Code
- JWZKit, Screening, Trichomonas1Product Code
- JXAKit, Screening, Urine1Product Code
- JXBKit, Identification, Yeast1Product Code
- JXCKit, Screening, Yeast1Product Code
- KZBAutomated Colony Counter1Product Code
- KZCManual Colony Counter1Product Code
- KZICulture Media, Enriched1Product Code
- KZJDevice, Gas Generating1Product Code
- KZKReader, Zone, Automated1Product Code
- LGADevice, Oxidase Test For Gonorrhea3Product Code
- LIBDevice, General Purpose, Microbiology, Diagnostic1Product Code
- LIODevice, Specimen Collection1Product Code
- LJFDevice, Antimicrobial Drug Removal1Product Code
- LJGQuality Control Slides1Product Code
- LKSDevice, Parasite Concentration1Product Code
- LLHReagents, Clostridium Difficile Toxin1Product Code
- LQLGram Positive Identification Panel1Product Code
- LQMGram Negative Identification Panel1Product Code
- LRHInstrument For Auto Reader Of Overnight Microorganism Identification System1Product Code
- LSCNeisseria Controls1Product Code
- LTSTest Reagents, Neisseria Gonorrhoeae Biochemical1Product Code
- MCBAntigen, C. Difficile1Product Code
- MDBSystem, Blood Culturing1Product Code
- MJKDna Probe, Trichomonas Vaginalis1Product Code
- MJMDna Probe, Gardnerella Vaginalis1Product Code
- MLADna Probe, Yeast1Product Code
- NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast1Product Code
- OMNC. Difficile Nucleic Acid Amplification Test Assay1Product Code
- OUSMethicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt1Product Code
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System2Product Code
- PPUMicrobial Colony Image Assessment System2Product Code
- PQZGbs Culture Media, Selective And Differential1Product Code
- QBDMicrobial Nucleic Acid Storage And Stabilization Device2Product Code
- QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture1Product Code
- QMCTransport Medium, Notified Per The Vtm Guidance1Product Code
- QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms2Product Code
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- 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
STREP-SURE A/E
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K941111
- 510(k) Type
- Traditional
- Applicant
- CLINICAL STANDARDS LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/1994
- Days to Decision
- 148 days
- Submission Type
- Statement