Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)2Cleared 510(K)
- K231031ACL TOP Family 70 Series2Cleared 510(K)
- K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)2Cleared 510(K)
- K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS2Cleared 510(K)
- K091980ACL TOP 700 LAS2Cleared 510(K)
- K073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)2Cleared 510(K)
- K063679ACL TOP2Cleared 510(K)
- K033414ACL TOP MODEL, TOP2Cleared 510(K)
- K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -5602Cleared 510(K)
- K023362FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN2Cleared 510(K)
- K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-70002Cleared 510(K)
- K001645SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-15002Cleared 510(K)
- K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C2Cleared 510(K)
- K001145SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-60002Cleared 510(K)
- K993299SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-15002Cleared 510(K)
- K993174SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-60002Cleared 510(K)
- K992763SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-5002Cleared 510(K)
- K992423SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-5002Cleared 510(K)
- K992321SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-60002Cleared 510(K)
- K991101COAG-A-MATE MAX2Cleared 510(K)
- K981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)2Cleared 510(K)
- K964139SYSMEX CA-60002Cleared 510(K)
- K962857COAG-A-MATE MTX2Cleared 510(K)
- K962664ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER2Cleared 510(K)
- K961991ACL 6000 SYSTEM (ACL 6000)2Cleared 510(K)
- K961579STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER2Cleared 510(K)
- K954437THROMBELASTOGRAPH COAGULATION ANALYZER 3000S2Cleared 510(K)
- K951072PROTIME MICROCOAGULATION SYSTEM2Cleared 510(K)
- K943153MICROSAMPLE COAGULATION ANALYZER2Cleared 510(K)
- K944227ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER2Cleared 510(K)
- K942117STA AUTOMATED MULTI-PARAMETRIC ANALYZER2Cleared 510(K)
- K931992HEMOLAB2Cleared 510(K)
- K933092TAS ANALYZER2Cleared 510(K)
- K931956CASCADE M, CAT. NO. 17102Cleared 510(K)
- K931206ELECTRA 1600C AUTOMATIC COAGULATION TIMER2Cleared 510(K)
- K924098IL MCL-2 COAGULATION ANALYZER2Cleared 510(K)
- K921465CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)2Cleared 510(K)
- K921363CASCADE 4802Cleared 510(K)
- K914946CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION2Cleared 510(K)
- K904297ST-4 COAGULATION INSTRUMENT2Cleared 510(K)
- K904204THROMBELASTOGRAPH2Cleared 510(K)
- K901380CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 14302Cleared 510(K)
- K901120KOAGULAB 60-S COAGULATION SYSTEM2Cleared 510(K)
- K895844THROMBELASTOGRAPH(R)2Cleared 510(K)
- K894052ELECTRA 1000C AUTOMATIC COAGULATION TIMER2Cleared 510(K)
- K885035KOAGULAB* 32-S COAGULATION SYSTEM2Cleared 510(K)
- K884863ELECTRA 900C AUTOMATIC COAGULATION TIMER2Cleared 510(K)
- K881281COAG-A-MATE(R) XM2Cleared 510(K)
- K813564COAG-A-MATE X22Cleared 510(K)
- GKRSystem, Hemoglobin, Automated2Product Code
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- 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
HEMOLAB
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K931992
- 510(k) Type
- Traditional
- Applicant
- BIOMERIEUX VITEK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/22/1994
- Days to Decision
- 608 days
- Submission Type
- Summary