meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
36
Latest Decision
1997-05-05

Clearances · page 14 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K970431 BEHRING COAGULATION SYSTEM Behring Diagnostics, Inc. JPA Class II 1997-05-05
K970593 UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA Universal Reagents, Inc. GJT Class II 1997-04-25
K970607 UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA Universal Reagents, Inc. GJT Class II 1997-04-25
K962571 COAGUCHEK PST SYSTEM Boehringer Mannheim Corp. GJS Class II 1997-04-22
K963844 HYDRAGEL 15 HB A1C KIT Morax LCP Class II 1997-04-22
K951640 HUMAN PROTEIN S RID TEST KIT The Binding Site, Ltd. GGP Class II 1997-04-21
K970331 CBC-4K HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 1997-04-16
K965113 N-ASSAY TIA FIBRINOGEN TEST KIT Crestat Diagnostics, Inc. KQJ Class II 1997-04-16
K964946 SYSMEX CA-1000/SYSMEX CA-5000 Sysmex Corp. JPA Class II 1997-03-18
K965076 MDA HEPARIN ANTI-X ASSAY Organon Teknika Corp. KFF Class II 1997-03-18
K964934 THROMBONOSTIKA F1.2 Organon Teknika Corp. MIF Class II 1997-03-18
K964375 SYSMEX SE/RAM-1 Sysmex Corp. GKL Class II 1997-03-13
K961835 PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp. GJS Class II 1997-03-12
K961892 SPECKTIN-LA TEST SET Analytical Control Systems, Inc. GFO Class II 1997-03-07
K964609 ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE Array Medical, Inc. JBP Class II 1997-03-06
K960072 SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX Biochem Immunosystems (U.S.), Inc. GKZ Class II 1997-03-06
K951632 ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1997-03-06
K964988 COULTER AC.T SERIES ANALYZER Coulter Corp. GKZ Class II 1997-03-06
K964963 LYPHOCHEK COAGULATION CONTROL Bio-Rad GGN Class II 1997-02-20
K964452 HEMATACHEK Richmond Diagnostics, Inc. GLK Class II 1997-02-20
K964139 SYSMEX CA-6000 Dade Intl., Inc. GKP Class II 1997-02-06
K965047 MINK LUNG CELL CULTURE Neogenex KIR Class I 1997-02-04
K963263 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 Coulter Corp. GKZ Class II 1997-01-22
K964754 ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE Ortho Diagnostic Systems, Inc. GKZ Class II 1997-01-22
K962857 COAG-A-MATE MTX Organon Teknika Corp. GKP Class II 1997-01-22
K964856 CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. GKZ Class II 1997-01-17
K962768 CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL Coulter Corp. GKZ Class II 1997-01-06
K962305 CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL Coulter Corp. GKZ Class II 1997-01-06
K963111 COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S Chromogenix AB GGW Class II 1996-12-23
K964618 CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 Coulter Corp. GKZ Class II 1996-12-23
K964270 UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA Universal Reagents, Inc. GGP Class II 1996-12-18
K964459 UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA Universal Reagents, Inc. GGP Class II 1996-12-18
K962864 THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS Alko Diagnostic Corp. KRZ Class II 1996-12-18
K962968 PROC APC ASSAY, PROC CONTROL PLASMA Behring Diagnostics, Inc. GGP Class II 1996-12-13
K963963 MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS Becton Dickinson Immunocytometry Systems GKZ Class II 1996-12-12
K961908 THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 Helena Laboratories JPA Class II 1996-12-10
K963902 QUANTITATIVE FIBRINOGEN ASSAY Ortho Diagnostic Systems, Inc. GIS Class II 1996-11-29
K963954 CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY Caltag Laboratories, Inc. GKZ Class II 1996-11-25
K963106 CHROMOLIZE PAI-1 KIT Medical Diagnostic Technologies, Inc. GGP Class II 1996-11-18
K962825 SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY Shield Diagnostics, Ltd. GGP Class II 1996-11-15
K961062 FLEXSURE OBT Smithkline Diagnostics, Inc. KHE Class II 1996-11-06
K964052 HEMOCUE HEMOTROL Direct Solutions GGM Class II 1996-11-06
K962633 VEGA HEMATOLOGY ANALYZER Abx, Inc. GKZ Class II 1996-11-04
K962988 COULTER GEN-S SYSTEM Coulter Corp. GKL Class II 1996-10-30
K961054 SYSMEX UF-100 Sysmex Corp. LKM Class II 1996-10-28
K962675 STA - LIATEST VWF TEST KIT American Bioproducts Co. GJT Class II 1996-10-25
K962426 CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 Chrono-Log Corp. JOZ Class II 1996-10-22
K961439 ABBOTT CELL-DYN 4000 SYSTEM Abbott Diagnostics GKZ Class II 1996-10-18
K962176 TPP Panbio, Inc. MIF Class II 1996-10-18
K963908 HEMOCUE HEMOLIN Direct Solutions GGM Class II 1996-10-16
K961929 FACTOR DEFICIENT PLASMA Universal Reagents, Inc. GGP Class II 1996-10-10
K955715 CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) Abbott Laboratories GKZ Class II 1996-10-08
K961674 ROCHE UNIMATE FRUCTOSAMINE REAGENT Roche Diagnostic Systems, Inc. LCP Class II 1996-09-27
K961312 HEMOCUE B-HEMOGLOBIN SYSTEM Hemocue, Inc. GKR Class II 1996-09-24
K962671 STA-VWF CALIBRATOR KIT American Bioproducts Co. GJT Class II 1996-09-13
K960875 KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) Sigma Diagnostics, Inc. JPA Class II 1996-09-10
K962664 ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER Medical Laboratory Automation Systems, Inc. GKP Class II 1996-09-10
K961991 ACL 6000 SYSTEM (ACL 6000) Instrumentation Laboratory CO GKP Class II 1996-09-04
K954607 RETICULOCYTE METHOD Bayer Corp. GKL Class II 1996-08-30
K962780 FRESHCELLS, HEP-2 Diagnostic Hybrids, Inc. KIR Class I 1996-08-29
K962311 FRESHFROZENCELLS Diagnostic Hybrids, Inc. KIR Class I 1996-08-29
K962306 FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES Diagnostic Hybrids, Inc. KIR Class I 1996-08-29
K962782 FRESHFROZEN CELLS, HEP-2 Diagnostic Hybrids, Inc. KIR Class I 1996-08-29
K954594 RETICULOCYTE METHOD, RBC INDICES Bayer Corp. GKZ Class II 1996-08-23
K955719 SICKLE-2000 Medicus Technologies, Inc. GIQ Class II 1996-08-14
K960871 SPECTROLYSE ANTITHROMBIN III (ANTI-XA) Medical Diagnostic Technologies, Inc. JBQ Class II 1996-08-14
K961814 THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS Cardiovascular Diagnostics, Inc. GIZ Class II 1996-08-13
K960749 HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT International Technidyne Corp. JBP Class II 1996-08-12
K962489 CHROMOLIZE TPA ASSAY KIT Medical Diagnostic Technologies, Inc. GGP Class II 1996-07-31
K962407 N/T PROTEIN CONTROL PY Behring Diagnostics, Inc. GIL Class II 1996-07-29
K961807 CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 Ciba Corning Diagnostics Corp. GLK Class II 1996-07-26
K962674 STA - VWF CONTROL [N]+[P] KIT American Bioproducts Co. GGN Class II 1996-07-23
K961278 COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS Coulter Corp. GKZ Class II 1996-07-22
K961701 MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE Dako Corp. GKZ Class II 1996-07-16
K961673 R&D RETIC-PG HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 1996-07-15
K961579 STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. GKP Class II 1996-07-10
K955608 MCCOY CELL CULTURES Vai Diagnostics, Inc. KIR Class I 1996-07-08
K961803 SPUNCRIT (MODEL DRC-40) Micro Diagnostics Corp. GKG Class II 1996-07-05
K960947 SAS SICKLE CELL TEST Sa Scientific, Inc. GHM Class II 1996-07-01
K961610 R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) R&D Systems, Inc. GKZ Class II 1996-07-01
K961938 STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS Nova Biomedical Corp. GJS Class II 1996-06-28
K953741 THERMACYL BLOOD/FLUID WARMER Baxter Healthcare Corp BSB Class II 1996-06-26
K954202 PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS Medtronic Hemotec, Inc. JPA Class II 1996-06-20
K961435 MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE Dako Corp. GKZ Class II 1996-06-14
K960531 MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE Dako Corp. GKZ Class II 1996-06-14
K955087 HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS Bayer Corp. LCP Class II 1996-06-13
K961623 FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS Becton Dickinson Monoclonal Center GKZ Class II 1996-06-07
K960438 TINTELIZE PAI-1 KIT Medical Diagnostic Technologies, Inc. GGP Class II 1996-06-05
K942525 MEDICOUNT DEKA HEMATOLOGY ANALYZER Cea America Corp. GKZ Class II 1996-06-05
K961189 TAS A PTT TEST CONTROLS Cardiovascular Diagnostics, Inc. GGN Class II 1996-06-05
K960909 H292 CELL CULTURE Neogenex KIR Class I 1996-05-30
K955278 BEHRING COAGULATION TIMER Behring Diagnostics, Inc. GGN Class II 1996-05-30
K960234 TAS HMT CONTROLS Cardiovascular Diagnostics, Inc. GGN Class II 1996-05-30
K952559 ERYTHROPOIETIN IMMUNOASSAY KIT Nichols Institute GGT Class II 1996-05-29
K960894 CD-CHEX + RBC Streck Laboratories, Inc. GGL Class II 1996-05-24
K961370 LA POSITIVE CONTROL PLASMA Medical Diagnostic Technologies, Inc. GGC Class II 1996-05-24
K951461 NCI-H292 CELL CULTURE Viromed Laboratories, Inc. KIR Class I 1996-05-22
K960774 MICRO21 WITH ANA Triangle Biomedical Sciences, Inc. JOY Class II 1996-05-22
K951440 LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE Viromed Laboratories, Inc. KIR Class I 1996-05-22
K955673 CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) Abbott Laboratories GKZ Class II 1996-05-20

4,197 clearances in the Hematology panel. Data: openFDA.