meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
42
Latest Decision
2000-08-31

Clearances · page 11 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K002528 SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION Sienco, Inc. JBP Class II 2000-08-31
K002400 MODIFICATION OF ACL ADVANCE Instrumentation Laboratory CO JPA Class II 2000-08-30
K001420 SLIDESCAN Applied Imaging Corp. JOY Class II 2000-08-30
K001462 CARESIDE HEMOGLOBIN Careside, Inc. KHG Class II 2000-08-21
K001392 GLYCOSAL HBA1C TEST Provalis Diagnostics , Ltd. LCP Class II 2000-08-21
K001683 SYSMEX R-500 Sysmex Corporation of America GKL Class II 2000-08-21
K001645 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. GKP Class II 2000-08-04
K000887 DRX HBA1C Metrika, Inc. LCP Class II 2000-07-26
K001891 MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C Bio/Data Corp. GKP Class II 2000-07-12
K994238 IL TEST LIQUID ANTITHROMBIN Instrumentation Laboratory CO JBQ Class II 2000-06-23
K001064 BEHRING COAGULATION TIMER ANALYZER (BCT) Dade Behring, Inc. JPA Class II 2000-06-21
K001067 DADE BEHRING COAGULATION ANALYZER (BCT) Dade Behring, Inc. JPA Class II 2000-06-20
K000492 MDA D-DIMER Organon Teknika Corp. DAP Class II 2000-06-07
K992799 SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT Sangui Biotech, Inc. GGT Class II 2000-06-07
K000973 BEHRING COAGULATION SYSTEM (BCS) Dade Behring, Inc. JPA Class II 2000-05-26
K992085 ABBOTT IMX GLYCATED HEMOGLOBIN II Abbott Laboratories LCP Class II 2000-05-25
K001256 CONTROL PLASMA N Dade Behring, Inc. GIZ Class II 2000-05-24
K993131 NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY Primus, Inc. LCP Class II 2000-05-22
K001043 KAWASUMI LABORATORY BLOOD DRAWING KIT Kawasumi Laboratories America, Inc. KSB Class II 2000-05-19
K000611 STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER Bd Biosciences GKZ Class II 2000-05-18
K001145 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 Dade Behring, Inc. GKP Class II 2000-05-11
K000578 SERIM LEUKOCYTE ESTERASE TEST STRIPS Serim Research Corp. LJX Class I 2000-05-05
K000897 CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE Bd Biosciences GKZ Class II 2000-05-05
K993678 THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES Haemoscope Corp. JPA Class II 2000-05-05
K000361 K-ASSAY AT-III Kamiya Biomedical Co. JBQ Class II 2000-04-26
K000649 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. GGP Class II 2000-04-25
K993356 COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES Coulter Corp. GKZ Class II 2000-04-20
K000945 PARA 12 PLUS RETICS Streck Laboratories, Inc. GLQ Class II 2000-04-18
K000398 SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 Shield Diagnostics, Ltd. GGP Class II 2000-04-17
K000373 939UDX URINE PATHOLOGY SYSTEM Intl. Remote Imaging Systems LKM Class II 2000-04-14
K000528 ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 Sigma Diagnostics, Inc. GIR Class I 2000-04-07
K000527 ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 Sigma Diagnostics, Inc. GIR Class I 2000-04-07
K994194 (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT Cardiovascular Diagnostics, Inc. JBP Class II 2000-03-28
K000115 RETIC CHEX LINEARITY Streck Laboratories, Inc. JPK Class II 2000-03-27
K000679 THROMBOSTRATE CONTROL PLASMAS Pacific Hemostasis GGN Class II 2000-03-24
K000239 GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL Genzyme Corp. LCP Class II 2000-03-21
K000053 ACL 9000 SYSTEM Instrumentation Laboratory CO JPA Class II 2000-03-15
K993957 DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR Dako Corp. MYA Class II 2000-03-03
K000076 CELL-CHEX Streck Laboratories, Inc. GJR Class II 2000-03-03
K994341 FIBRINOGEN CALIBRATOR KIT Dade Behring, Inc. GFX Class II 2000-03-03
K994356 IMMUNOCYT Diagnocure, Inc. NBK Class II 2000-02-23
K994100 PACIFIC HEMOSTASIS THROMBOPLASTIN D Pacific Hemostasis GJS Class II 2000-02-18
K993332 GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 Gradipore , Ltd. GGC Class II 2000-02-16
K994159 HMP CONTROLS (TAS) RAPIDPOINT Cardiovascular Diagnostics, Inc. GGN Class II 2000-02-15
K992571 I-STAT SYSTEM I-Stat Corp. JBP Class II 2000-02-10
K994006 AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) Avocet Medical, Inc. GJS Class II 2000-02-03
K993553 GTI-FVIII INHIBITOR ASSAY Genetic Testing Institute GGP Class II 2000-02-01
K992957 ADVANCED D-DIMER Dade Behring, Inc. DAP Class II 2000-01-28
K993519 RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST Cardiovascular Diagnostics, Inc. JOX Class II 2000-01-14
K994388 XE CHECK Streck Laboratories, Inc. GLQ Class II 2000-01-14
K994073 HEMOSITE TEST SYSTEM Gds Technology, LLC KHG Class II 2000-01-14
K992851 ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM Roche Diagnostics Corp. JBP Class II 2000-01-14
K992959 BEHRING COAGULATION SYSTEM (BCS) Dade Behring, Inc. JPA Class II 2000-01-11
K993590 FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET Pointe Scientific, Inc., LCP Class II 1999-12-21
K992456 GRADILEIDEN V TEST Gradipore , Ltd. GGW Class II 1999-12-21
K990899 HEMOCHEK-A1C SAMPLE COLLECTION KIT Osborn Group, Inc. LCP Class II 1999-12-21
K994045 PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 Primus Corp. LCP Class II 1999-12-21
K991439 POLLER CALIBRANTS European Concerted Action on Anticoagulation GGN Class II 1999-12-20
K992531 ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM Accumetrics, Inc. JOZ Class II 1999-12-20
K993375 CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER Clinical Diagnostic Solutions, Inc. KRX Class II 1999-12-20
K991246 FRUCTOSAMINE, MODEL FR 106-01 A.P. Total Care, Inc. LCP Class II 1999-12-16
K993276 SIMPLIFY D-DIMER, MODEL DCGK1 Agen Biomedical , Ltd. GHH Class II 1999-12-14
K993299 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. GKP Class II 1999-12-07
K993482 K-ASSAY FIBRINOGEN Kamiya Biomedical Co. GIS Class II 1999-12-06
K992711 SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 Sigma Diagnostics, Inc. GFO Class II 1999-12-06
K992759 COLON ALERT TEST Immunostics Inc., KHE Class II 1999-12-06
K992712 SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 Sigma Diagnostics, Inc. GFO Class II 1999-12-06
K993104 STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR Nova Biomedical Corp. GLY Class II 1999-12-02
K990398 PLATELETWORKS Array Medical, Inc. JOZ Class II 1999-12-01
K993496 RETIC-QUINOX Hematronix, Inc. JPK Class II 1999-11-30
K993825 PARA TECH PLUS RETICS Streck Laboratories, Inc. JCN Class II 1999-11-30
K993126 CD-CHEX CD 34 Streck Laboratories, Inc. GGL Class II 1999-11-26
K991850 SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC Biosafe Laboratories, Inc. LCP Class II 1999-11-26
K992887 STAK-CHEX PLUS RETICS Streck Laboratories, Inc. GLQ Class II 1999-11-22
K992829 CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 Medical Analysis Systems, Inc. GGN Class II 1999-11-22
K991286 AVOCET ACUSURE SYSTEM Avocet Medical, Inc. GJS Class II 1999-11-18
K993321 R&D HGB/GLC WHOLE BLOOD CONTROL R&D Systems, Inc. GGM Class II 1999-11-12
K992921 PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II Primus Corp. LCP Class II 1999-11-12
K992875 SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER Sysmex Corp. GKZ Class II 1999-11-09
K993174 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 Dade Behring, Inc. GKP Class II 1999-11-09
K992492 PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM Roche Diagnostics Corp. GJS Class II 1999-11-02
K991483 ABBOTT ARCHITECT GLYCATED HEMOGLOBIN Abbott Laboratories LCP Class II 1999-11-01
K992704 IL TEST VON WILLEBRAND FACTOR Instrumentation Laboratory CO GGP Class II 1999-11-01
K992511 ABX PENTRA 60 HEMATOLOGY ANALYZER Abx Diagnostics GKZ Class II 1999-10-15
K990992 INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC Roche Diagnostics Corp. LCP Class II 1999-09-30
K992444 MODIFICATION OF: CELL-DYN 1200 SYSTEM Abbott Laboratories GKZ Class II 1999-09-24
K992849 QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1999-09-23
K992423 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 Dade Behring, Inc. GKP Class II 1999-09-21
K992763 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 Dade Behring, Inc. GKP Class II 1999-09-21
K992199 ACID HEMOGLOBIN KIT Helena Laboratories JBD Class II 1999-09-21
K992321 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 Dade Behring, Inc. GKP Class II 1999-09-17
K990641 CALTAG FETAL HEMOGLOBIN TEST Caltag Laboratories, Inc. GHQ Class II 1999-09-17
K991159 PRISMATHERM II, ASTOLINE Stihler Electronic GmbH BSB Class II 1999-09-03
K992130 PACIFIC HEMOSTASIS THROMBOSCREEN 400C Pacific Hemostasis KQG Class II 1999-09-03
K991160 ASTOTHERM PLUS, ASTOTUBES, ASTOLINE Stihler Electronic GmbH BSB Class II 1999-09-02
K992278 HEPARIN CONTROL PLASMA LEVEL 1 Pacific Hemostasis GGN Class II 1999-08-26
K992279 HEPARIN CONTROL PLASMA LEVEL 2 Pacific Hemostasis GGN Class II 1999-08-26
K984567 VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) Ventana, Inc. MYA Class II 1999-08-12
K991839 ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER Abx Diagnostics GKZ Class II 1999-08-11
K990580 CRYOCHECK LA SURE, MODEL SUR25-10 Precision Biologic GIR Class I 1999-07-28

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