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
- JTQBath, Incubators/Water, All1Product Code
- JTRKit, Quality Control For Culture Media1Product Code
- JTWSystem, Transport, Aerobic1Product Code
- K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM1Cleared 510(K)
- K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K022874GEN-PROBE APTIMA COMBO 2 ASSAY1Cleared 510(K)
- K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM1Cleared 510(K)
- K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)1Cleared 510(K)
- K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)1Cleared 510(K)
- K934894CULTURESWAB TRANSPORT SYSTEM1Cleared 510(K)
- K904773P AND T MEDIUM1Cleared 510(K)
- K895187FDL, INC.'S TRANSPORT SYSTEM1Cleared 510(K)
- K882580MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE1Cleared 510(K)
- K872325GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT1Cleared 510(K)
- K872326GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT1Cleared 510(K)
- K843359URINE TRANSPORT KIT1Cleared 510(K)
- K843341GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK1Cleared 510(K)
- K843173CELL-MATICS VIRAL TRANSPORT PACK1Cleared 510(K)
- K840719BAKTERIETTE-VI-PAK1Cleared 510(K)
- K840990PRESERV CARY BLAIR TRANSPORT PACK1Cleared 510(K)
- K840991PRESERV BUFFERED GLYCEROL SALINE1Cleared 510(K)
- K840968PRESERV TRANSPORT & CULTURE PACK1Cleared 510(K)
- K831579GONORRHEA TRANSETTE 1 & 31Cleared 510(K)
- K830250CVT VIRAL TRANSPORTS1Cleared 510(K)
- K823443HERPES TRANSETTE1Cleared 510(K)
- K811284GC TTANSPORT SYSTEM1Cleared 510(K)
- K811283JEMBEC TRANSPORT SYSTEM1Cleared 510(K)
- K803298MINI-TIP CULTURETTE1Cleared 510(K)
- K802563TRANSETTE SYSTEM/COLLECTION & TRANSP1Cleared 510(K)
- K802023CULSWAB CAT.#978 & 9791Cleared 510(K)
- K791953PDC 304 DOUBLE SWAB CULTURE COLLECTION1Cleared 510(K)
- K791924PDC 104 SINGLE SWAB CULTURE COLLECTION1Cleared 510(K)
- K790366URINE CULTURE KIT1Cleared 510(K)
- K780440CHAMBER, AEROBIC1Cleared 510(K)
- K772209CULTURE COLLEC. TRANS. SYS., DOUBLE DRY1Cleared 510(K)
- K772207CULTURE COLLEC. TRANS. SYS., SINGLE WET1Cleared 510(K)
- K772208CULTURE COLLEC. TRANS. SYS., SINGLE DRY1Cleared 510(K)
- K772205CULTURE COLLEC. TRANS. SYS., DOUBLE WET1Cleared 510(K)
- K772210CULTURE COLLEC. TRANS. SYS., DOUBLE WET1Cleared 510(K)
- K772206CULTURE COLLEC. TRANS. SYS., SINGLE WET1Cleared 510(K)
- K771058EPTONE BACK-UP BROTH, VACUTAINER1Cleared 510(K)
- K770957PEDIATRIC BLOOD CULTURE BOTTLES1Cleared 510(K)
- K770683BOTTLE, BLOOD CULTURE, BI-PHASIC1Cleared 510(K)
- K760458BOTTLE, BLOOD CULTURE, SCHAEDLER1Cleared 510(K)
- K760054CULTURE TUBE, (VACUTAINER)1Cleared 510(K)
- 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
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K882580
- 510(k) Type
- Traditional
- Applicant
- PRECISION DYNAMICS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/8/1988
- Days to Decision
- 17 days