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
- K924907FILTERMATE UNIVERSAL HARVESTER1Cleared 510(K)
- K901808MICROMATE 196 MODEL A9619601Cleared 510(K)
- K894645IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM1Cleared 510(K)
- K892369MULTI-PROBE HEAD PLUS1Cleared 510(K)
- K891765GENETIC SYSTEMS PIPETTOR/DILUTOR1Cleared 510(K)
- K891766GENETIC SYSTEMS MICROPLATE STRIP WASHER1Cleared 510(K)
- K891768GENETIC SYSTEMS MICROPLATE WASHER1Cleared 510(K)
- K884695WASHER 500 MICROELISA SYSTEM1Cleared 510(K)
- K884125BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL4031Cleared 510(K)
- K874598DYNATECH MR 250 MANUAL MICROELISA READER1Cleared 510(K)
- K873542MICROPLATE AUTO-WASHER (MOTORIZED STAGE)1Cleared 510(K)
- K871945MICROLAB AT1Cleared 510(K)
- K863423CODE-A-WELL SERIES 1-1000 AND SERIES 1-11001Cleared 510(K)
- K863374CODE-A-WELL SERIES 1-600, 1-6251Cleared 510(K)
- K862802MULTI-CHANNEL MICROPIPETTES1Cleared 510(K)
- K862066TITERTEK MICROPLATE WASHER S-121Cleared 510(K)
- K860617POLYPET1Cleared 510(K)
- K853920BIO-TEK EL 401 HANDHELD MICROPLATE WASHER1Cleared 510(K)
- K853380SPR 2 AUTODILUTER1Cleared 510(K)
- K851020MIC-CONCEPT INOCULATOR1Cleared 510(K)
- K851019MIC-CONCEPT INOCULUM SEED TRAY1Cleared 510(K)
- K850908TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA1Cleared 510(K)
- K850249BIO-TEK AUTOMATED MICROPLATE WASHER EL4021Cleared 510(K)
- K850371INTIWASH MANUAL MICROPLATE WASHER1Cleared 510(K)
- K844893SLT 223 DISPENSER FOR MICROTITERPLATES1Cleared 510(K)
- K844891SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES1Cleared 510(K)
- K844568TITERTEK DULUTER/DISPENSER 78-640-001Cleared 510(K)
- K844552BIO-STAT III PLATE WASHER1Cleared 510(K)
- K844500TITERTEK MICROPLATE WASHER 1201Cleared 510(K)
- K843272T.I.M.E. DISPENSER1Cleared 510(K)
- K842848CODE-A-WELL 350 MICROTITRATION STRIPS1Cleared 510(K)
- K831462API UNISCEPT PLUS 140 INOCULATOR1Cleared 510(K)
- K832203MULTI-TITER DISPENSER1Cleared 510(K)
- K831640WASHER 6000 MICRO-C LISA SYSTEM1Cleared 510(K)
- K831644PIPETTE 12 CHANNEL1Cleared 510(K)
- K831341API UNISCEPT PLUS AUTOINOCULATOR1Cleared 510(K)
- K830059MUELLER HINTON W/50% SHEEP BLOOD1Cleared 510(K)
- K823137OCTAPETTES1Cleared 510(K)
- K823218DISPOSABLE DISPENSE MANIFOLD1Cleared 510(K)
- K82196196 WELL DISPENSER1Cleared 510(K)
- K820992MICROPLATE WASHING DEVICE1Cleared 510(K)
- K820821MIC-2000 PLUS, 96 CHANNEL DISPENSER1Cleared 510(K)
- K812860IMMUNOASSAY PLATE1Cleared 510(K)
- K812818TITERTEK AUTODROP1Cleared 510(K)
- K810719REPLICA PLATER1Cleared 510(K)
- K810659AUTODILUTER III1Cleared 510(K)
- K810229SCEPTOR SYSTEM AUTOMATED MODEL 2161Cleared 510(K)
- K803244ASSAY STRIPS1Cleared 510(K)
- K810039MIC-2000 INOCULUM TRAY LID1Cleared 510(K)
- K803242SEROCLUSTER EIA PLATES1Cleared 510(K)
- K803243SEROCLUSTER FLEXIBLE VINYL U & V PL.1Cleared 510(K)
- K810022SRD III1Cleared 510(K)
- K803252MICROMEDIC REAGENT DISPENSER1Cleared 510(K)
- K802857IMMULON REMOVAWELL STRIPS #011-010-63011Cleared 510(K)
- K801305HIPPURATE DISK1Cleared 510(K)
- K801437DISPENSING SEROLOGICAL PIPET1Cleared 510(K)
- K800989DYNAWASHER II1Cleared 510(K)
- K800240SEROCLUSTER U AND V1Cleared 510(K)
- K790974MIC-2000 INOCULATOR TEMPLATE1Cleared 510(K)
- K790971MIC-2000 QUAD INOCULUM TRAY1Cleared 510(K)
- K790957HISTO-DISPENSER1Cleared 510(K)
- K790956HISTO-OILER1Cleared 510(K)
- K790076INOCULATOR, MIC-2000 DISPOSABLE1Cleared 510(K)
- K781802WASHER SYSTEM, MICROELISA1Cleared 510(K)
- K781942MINIWASH1Cleared 510(K)
- K761149MODEL 203 DISPENSER1Cleared 510(K)
- JTLPlasma, Coagulase, Human, Horse And Rabbit1Product Code
- JTMAnaerobic Box Glove1Product Code
- JTODiscs, Strips And Reagents, Microorganism Differentiation1Product Code
- 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
ASSAY STRIPS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K803244
- 510(k) Type
- Traditional
- Applicant
- CORNING COSTAR CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/2/1981
- Days to Decision
- 41 days