meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
41
Latest Decision
1991-06-10

Clearances · page 21 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K911347 LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL Bio-Rad JCM Class II 1991-06-10
K911582 STAK-CHEX Streck Laboratories, Inc. JCN Class II 1991-05-28
K910680 EPINEPHRINE REAGENT, CAT. NO. 5367 Helena Laboratories GHR Class II 1991-05-20
K910800 ADP REAGENT Helena Laboratories GHR Class II 1991-05-20
K910706 COLLAGEN REAGENT CAT. NO. 5368 Helena Laboratories GHR Class II 1991-05-20
K904253 ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY Ortho Diagnostic Systems, Inc. GKZ Class II 1991-05-20
K910181 HITT BY HEMOCHRON(R) International Technidyne Corp. KFF Class II 1991-05-10
K910834 QBC AUTOREADER Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1991-05-07
K910679 GENESIS I AUTOMATED CELL COUNTER Alicia Diagnostics, Inc. GKL Class II 1991-05-07
K905782 FHT (FECAL HEME TEST) Aerscher, Inc. KHE Class II 1991-05-06
K910636 ABS CADKIT Panbio, Inc. GIS Class II 1991-04-29
K910741 HEPARIN CONTROLS, HIGH AND LOW Sigma Diagnostics, Inc. KFF Class II 1991-04-29
K905807 HELENA THROMBOPLASTIN REAGENT WITH DILUENT Helena Laboratories GJS Class II 1991-04-16
K910430 HEMOCARD-AS Isolab, Inc. GHM Class II 1991-04-15
K905643 BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY Agen Biomedical , Ltd. GHH Class II 1991-04-12
K910283 DANAM DATACELL-18 Danam Electronics GKZ Class II 1991-04-12
K910286 PLATELET AGGREGATION REAGENTS Medical Diagnostic Technologies, Inc. GHR Class II 1991-03-19
K910431 HEMOCARD CONTROL Isolab, Inc. JCM Class II 1991-03-11
K905857 HELENA THROMBOPLASTIN REAGENT, MODIFICATION Helena Laboratories GJS Class II 1991-02-27
K910105 PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 International Technidyne Corp. GFT Class II 1991-02-26
K903468 DADE PROTEIN C CLOTTING ASSAY Baxter Healthcare Corp GGP Class II 1991-02-26
K905524 RETIC-CHEX Streck Laboratories, Inc. JPK Class II 1991-02-20
K903874 FIBRINOTEST(TM) - FIBRINOGEN ASSAY Haemachem, Inc. GIS Class II 1991-02-14
K905396 HEMASTIX REAGENT STRIPS Heraeus Kulzer, Inc. JIO Class II 1991-02-11
K905673 AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 Helena Laboratories GGN Class II 1991-02-11
K904027 ABBOTT VISION(TM) GLYCATED HB Abbott Laboratories LCP Class II 1991-02-07
K904325 COAG-1 PT-NC TEST CARD Cardiovascular Diagnostic Services GJS Class II 1991-01-25
K903531 ANTICARDIOLIPIN ANTIBODY TEST SYSTEM Medical Innovations Corp. GFO Class II 1991-01-25
K905110 LIATEST(R) AT III TEST KIT American Bioproducts Co. JBQ Class II 1991-01-24
K904247 FREE PROTEIN S REAGENT CAT. NO. 5363 Helena Laboratories GGP Class II 1991-01-18
K905513 GLYC-AFFIN(TM)-GA Isolab, Inc. LCP Class II 1991-01-15
K905301 THE THERATEST ACA TEST Theratest Laboratories, Inc. GFO Class II 1991-01-14
K904795 FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKH Class I 1990-12-31
K905203 COAGULATION REFERENCE PLASMA, NORMAL Medical Diagnostic Technologies, Inc. GIZ Class II 1990-12-28
K904336 NEW COBE SATURATION/HEMATOCRIT MONITOR Cobe Laboratories, Inc. GKF Class II 1990-12-27
K904814 GLYC-AFFIN GP Isolab, Inc. LCP Class II 1990-12-26
K904022 NITRO BLUE TETRAZOLIUM REDUCTION Sigma Chemical Co. GHD Class I 1990-12-18
K903037 LUPO-TEST REAGENT Gradipore , Ltd. GIR Class I 1990-12-17
K904390 ANTI-HUMAN LEU-2A (CD8) PE Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1990-12-17
K904454 HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION International Technidyne Corp. GJS Class II 1990-12-17
K903995 NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT Sigma Chemical Co. GHD Class I 1990-12-13
K904209 SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1990-12-11
K904003 HEMOCHRON(R) HEPARIN RESPONSE TEST Intensive Technology, Inc. KFF Class II 1990-11-29
K904297 ST-4 COAGULATION INSTRUMENT American Bioproducts Co. GKP Class II 1990-11-13
K904341 APTT REAGENT Sigma Chemical Co. GFO Class II 1990-11-08
K902614 ELVI 828 DIGICLOT MULTISCAN Logos Scientific, Inc. KQG Class II 1990-11-08
K901064 MONOHAEM (FECAL OCCULT BLOOD TEST) Silenus Laboratories Proprietary , Ltd. KHE Class II 1990-11-05
K904675 QBC SYSTEM MCHC Bd Becton Dickinson Vacutainer Systems Preanalytic JPJ Class II 1990-11-02
K904204 THROMBELASTOGRAPH Haemoscope Corp. GKP Class II 1990-11-01
K904637 QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1990-10-29
K904461 METER TRAX Hematronix, Inc. JPK Class II 1990-10-26
K903492 DSL ERYTHROPOIETIN (DSL # 1100) Diagnostic Systems Laboratories, Inc. GGT Class II 1990-10-26
K904464 CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED R&D Systems, Inc. JPK Class II 1990-10-23
K904073 COAGULATION REFERENCE PLASMA, ABNORMAL Medi-Tech, Inc. GGC Class II 1990-10-22
K903841 ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA Organon Teknika Corp. KFF Class II 1990-10-22
K903665 CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY Unipath , Ltd. GKZ Class II 1990-10-04
K902393 COACUTE ANTITHROMBIN CHROMOGENIC ASSAY Kabi Diagnostica JBQ Class II 1990-09-25
K902726 BARTELS EXTRACELLULAR MATRIX Baxter Healthcare Corp KIR Class I 1990-09-24
K903698 STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES Statspin Technologies JPI Class II 1990-09-17
K896830 OPTIMATE HEMOGLOBIN A1C Heraeus Kulzer, Inc. LCP Class II 1990-09-11
K902892 CELL-DYN CALIBRATOR Unipath , Ltd. KRZ Class II 1990-09-10
K902391 CELL-DYN 3000 CONTROL Unipath , Ltd. JCN Class II 1990-08-22
K902445 LYMPHO SEP(TM) Icn Biomedicals, Inc. JCF Class I 1990-08-22
K902639 EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) Incstar Corp. GGT Class II 1990-08-22
K902389 TRI-COUNT 16 Hematronix, Inc. JCN Class II 1990-08-22
K902311 GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. Applied Imaging Corp. LNJ Class II 1990-08-20
K902236 READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT Biosearch Medical Products, Inc. GGW Class II 1990-08-14
K902468 ACS ONE-STAGE PROTHROMBIN TIME REAGENT Analytical Control Systems, Inc. GJS Class II 1990-08-10
K902528 BIOCLOT C KIT Biopool AB GGP Class II 1990-08-09
K902530 SPECTROLYSE ATIII KIT Biopool AB JBQ Class II 1990-08-09
K902566 BIOPOOL PROTEIN C EID KIT AND BULK PLATES Biopool AB GGP Class II 1990-08-09
K902556 ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Analytical Control Systems, Inc. GFO Class II 1990-08-06
K901977 BECKMAN ANTITHROMBIN III REAGENT KIT Beckman Instruments, Inc. JBQ Class II 1990-08-06
K902458 ACS 0.02 M CALCIUM CHLORIDE Analytical Control Systems, Inc. JPA Class II 1990-08-01
K903019 MODIFIED COAG-1 PT TEST CARD Cardiovascular Diagnostic Services GJS Class II 1990-08-01
K902360 HEMA-SCREEN Immunostics Co., Inc. KHE Class II 1990-07-27
K902363 COAGULATION CONTROL, LEVEL III Sigma Chemical Co. GGN Class II 1990-07-26
K902362 COAGULATION CONTROL, LEVEL II Sigma Chemical Co. GGN Class II 1990-07-26
K902361 COAGULATION CONTROL, LEVEL I Sigma Chemical Co. GGN Class II 1990-07-26
K902455 ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) Analytical Control Systems, Inc. LCP Class II 1990-07-24
K902457 ABNORMAL GLYCOHEMOGLOBIN CONTROL Analytical Control Systems, Inc. LCP Class II 1990-07-24
K902263 OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION Trimedyne, Inc. GGX Class I 1990-07-23
K901874 COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY Kabi Diagnostica KFF Class II 1990-07-20
K902081 CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL Hemotec, Inc. JBP Class II 1990-07-03
K902210 ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA Ortho Diagnostic Systems, Inc. GGN Class II 1990-07-03
K902096 THROMBOPLASTIN WITH CALCIUM Sigma Chemical Co. GJS Class II 1990-07-03
K896582 DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) Primus, Inc. LCP Class II 1990-06-28
K902028 STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER Norfolk Scientific, Inc. JPI Class II 1990-06-20
K902083 CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE Helena Laboratories GJT Class II 1990-06-15
K901414 COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 Helena Laboratories LCP Class II 1990-06-15
K900718 ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY Roche Diagnostic Systems, Inc. LCP Class II 1990-06-12
K901875 PARA 12 PLUS Streck Laboratories, Inc. JCN Class II 1990-05-30
K901380 CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 Helena Laboratories GKP Class II 1990-05-25
K901327 ORTHO CORRECTION REAGENTS Ortho Diagnostic Systems, Inc. GJT Class II 1990-05-25
K901143 REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) Helena Laboratories JBD Class II 1990-05-23
K901120 KOAGULAB 60-S COAGULATION SYSTEM Ortho Diagnostic Systems, Inc. GKP Class II 1990-05-22
K900939 SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) Incstar Corp. KQJ Class II 1990-05-16
K900802 ANTI-HUMAN LEU-3A (CD4) FITC Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1990-05-15
K901325 THROMBOPLASTIN.C PLUS Baxter Healthcare Corp GJS Class II 1990-05-02
K900685 CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER Texas Intl. Laboratories, Inc. KQG Class II 1990-04-16

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