meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
32
Latest Decision
1993-12-06

Clearances · page 18 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K934351 APTT-ES REAGENT Medical Diagnostic Technologies, Inc. GFO Class II 1993-12-06
K934747 R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470 R & D Batteries, Inc. JPA Class II 1993-12-03
K932787 BATROXOBIN REAGENT Behring Diagnostics, Inc. JCO Class II 1993-11-29
K933475 TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 Miles, Inc. GKZ Class II 1993-11-22
K933478 TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 Miles, Inc. GKZ Class II 1993-11-22
K933092 TAS ANALYZER Cardiovascular Diagnostic Services GKP Class II 1993-11-15
K933432 STAGO FACTOR IX-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1993-11-15
K931183 GLYCOHEMOGLOBIN Teco Diagnostics LCP Class II 1993-11-05
K931906 NEW STACHROM PROTEIN C TEST KIT American Bioproducts Co. GGP Class II 1993-11-05
K931149 CA-1000 AUTOMATED COAGULATION ANALYZER Toa Medical Electronics USA, Inc. JPA Class II 1993-11-03
K921989 FDP - SLIDEX DIRECT Biomerieux Vitek, Inc. GHH Class II 1993-11-03
K932566 AGGRO/LINK CONTROL SOFTWARE Chrono-Log Corp. JBX Class II 1993-11-02
K932657 FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 More Diagnostics DAP Class II 1993-11-02
K933444 STAGO FACTOR XI-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1993-10-27
K933440 STAGO FACTOR VII-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1993-10-27
K933438 STAGO FACTOR XII-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1993-10-27
K933441 STAGO FACTOR X-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1993-10-27
K932011 PATHROMTIN Behring Diagnostics, Inc. GFO Class II 1993-10-25
K932145 COAGULATION REFERENCE PLASMA, NORMAL American Diagnostic Corp. GIZ Class II 1993-10-18
K933252 IL TEST (TM) PT-FIBRINOGEN HS PLUS Instrumentation Laboratory CO GJS Class II 1993-10-04
K932713 TRACE TRANSFERRIN REAGENT Trace Scientific , Ltd. DDQ Class II 1993-09-30
K932463 BIOCLOT LA Biopool AB GIR Class I 1993-09-27
K933188 DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI Baxter Diagnostics, Inc. JPA Class II 1993-09-22
K933010 BIOMERIEUX HEMOLAB COFAC VIII Biomerieux Vitek, Inc. GJT Class II 1993-09-15
K933287 745 GLYCOMAT Drew Scientific , Ltd. LCP Class II 1993-09-09
K930068 HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION Technidyne Corp. JPA Class II 1993-09-02
K930235 HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY Technidyne Corp. GGP Class II 1993-09-02
K923790 FACSORT FLOW CYTOMETER Becton Dickinson Immunocytometry Systems GKZ Class II 1993-09-01
K931206 ELECTRA 1600C AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. GKP Class II 1993-08-23
K932030 COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY Coulter Corp. GKZ Class II 1993-08-23
K931956 CASCADE M, CAT. NO. 1710 Helena Laboratories GKP Class II 1993-08-23
K930913 COULTER MH015 (DIFFERENTIAL CELL COUNTER) Coulter Corp. GKZ Class II 1993-08-23
K930823 PROTEIN-BOUND GLUCOSE ASSAYN KIT Diagnostic Specialties LCP Class II 1993-08-19
K932872 SICKLE CELL TEST KIT Histo-Med, Inc. JBB Class II 1993-08-16
K931503 REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) Helena Laboratories JBD Class II 1993-08-16
K931721 IL TEST FIBRINOGEN-C Instrumentation Laboratory CO KQJ Class II 1993-08-13
K924370 STACLOT(R) PNP TEST KIT American Bioproducts Co. GGW Class II 1993-08-09
K930454 BOEHRINGER MANNHEIM COAGUCHEK SYSTEM Boehringer Mannheim Corp. JPA Class II 1993-08-05
K924587 SIMULTEST CD3/ANTI-HLA-DR Becton Dickinson Immunocytometry Systems GKZ Class II 1993-08-05
K925670 IMS-200 Intelligent Medica Imaging, Inc. JOY Class II 1993-07-23
K931666 QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY R&D Systems, Inc. GGT Class II 1993-07-20
K930309 ABBOTT ENCOUNTER(TM)Q Abbott Laboratories GKZ Class II 1993-07-14
K931465 REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 Helena Laboratories JBD Class II 1993-07-06
K926124 CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON Coulter Corp. GKZ Class II 1993-07-06
K925200 BERICHROM HEPARIN Behring Diagnostics, Inc. KFF Class II 1993-06-28
K926390 PREDICTA ERYTHROPOIETIN KIT Genzyme Corp. GGT Class II 1993-06-25
K930685 TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) Heraeus Kulzer, Inc. GKL Class II 1993-06-22
K924098 IL MCL-2 COAGULATION ANALYZER Instrumentation Laboratory CO GKP Class II 1993-06-18
K931947 CHECKPOINT Medical Specialties, Inc. JPK Class II 1993-06-18
K924400 CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA Behring Diagnostics, Inc. GJT Class II 1993-06-08
K926422 VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY Syva Co. GGJ Class I 1993-06-02
K924396 CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA Behring Diagnostics, Inc. GJT Class II 1993-05-21
K930959 FACTOR CONTROL [P] American Bioproducts Co. GGC Class II 1993-05-20
K925494 BIOMERIEUX HEMOLAB FIBRINOMAT Biomerieux Vitek, Inc. GIS Class II 1993-05-18
K930157 TEST THROMBIN Behring Diagnostics, Inc. GJA Class II 1993-05-14
K931234 HEMOCARD CONTROL HB-AA, AE, FAA, FAE Isolab, Inc. JCM Class II 1993-05-11
K930148 TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) Heraeus Kulzer, Inc. GKZ Class II 1993-05-11
K930212 THROMBOPLATIN-M WITH CALCIUM Sigma Diagnostics, Inc. GJS Class II 1993-05-11
K924167 CRIT-LINE Noninvasive Medical Technology Corp. JPI Class II 1993-05-07
K930923 COAG-CONTROL American Bioproducts Co. GGC Class II 1993-04-27
K926012 ACS APCT REAGENT, MODIFIED Analytical Control Systems, Inc. GFO Class II 1993-04-27
K930849 VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA Organon Teknika Corp. JPA Class II 1993-04-20
K930327 IL TEST(TM) PROTEIN S Instrumentation Laboratory CO GGP Class II 1993-04-12
K922326 LUPO-TEST REGEANT Graoipore , Ltd. GIR Class I 1993-04-06
K922156 LUCOR CONFIRMATORY REAGENT Gradipore , Ltd. GIR Class I 1993-04-06
K930119 COULTER RETIC-C CELL CONTROL Coulter Electronics, Inc. JPK Class II 1993-04-05
K926469 VARIANT(TM) HEMOGLOBIN A 1C PROGRAM Bio-Rad LCP Class II 1993-03-29
K930391 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261 Proteins Intl., Inc. KIR Class I 1993-03-24
K930394 25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211 Proteins Intl., Inc. KIR Class I 1993-03-24
K930398 16 X 125 MM TEST TUBE, CATALOG #01-441 Proteins Intl., Inc. KIR Class I 1993-03-24
K930390 25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291 Proteins Intl., Inc. KIR Class I 1993-03-24
K930396 16 X 125 MM TEST TUBE, CATALOG #01-291 Proteins Intl., Inc. KIR Class I 1993-03-24
K930397 16 X 125 MM TEST TUBE, CATALOG Proteins Intl., Inc. KIR Class I 1993-03-24
K930393 ONE DRAM SHELL VIAL, CATALOG #02-261 Proteins Intl., Inc. KIR Class I 1993-03-24
K930395 ONE DRAM SHELL VIAL, CATALOG #02-461 Proteins Intl., Inc. KIR Class I 1993-03-24
K930392 16 X 125 MM TEST TUBE, CATALOG #01-111 Proteins Intl., Inc. KIR Class I 1993-03-24
K930369 25CM, 75CM, 150CM, FLASK, CATALOG #03-311 Proteins Intl., Inc. KIR Class I 1993-03-23
K930368 ONE DRAM SHELL VIAL, CATALOG #02-321 Proteins Intl., Inc. KIR Class I 1993-03-23
K930364 ONE DRAM SHELL VIAL, CATALOG # 02-241 Proteins Intl., Inc. KIR Class I 1993-03-23
K930386 16 X 125 MM TEST TUBE, CATALOG #01-401 Proteins Intl., Inc. KIR Class I 1993-03-23
K930372 16 X 125 MM TEST TUBE, CATALOG #01-311 Proteins Intl., Inc. KIR Class I 1993-03-23
K930382 ONE DRAMSHELL VIAL, CATALOG #02-421 Proteins Intl., Inc. KIR Class I 1993-03-23
K930384 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401 Proteins Intl., Inc. KIR Class I 1993-03-23
K930371 16 X 125 MM TEST TUBE, CATALOG #01-321 Proteins Intl., Inc. KIR Class I 1993-03-23
K930377 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461 Proteins Intl., Inc. KIR Class I 1993-03-23
K930370 ONE DRAM SHELL VIALS, CATALOG #02-311 Proteins Intl., Inc. KIR Class I 1993-03-23
K930389 ONE DRAM SHELL VIAL, CATALOG #02-291 Proteins Intl., Inc. KIR Class I 1993-03-23
K930381 ONE DRAM SHELL VIAL, CATALOG #02-441 Proteins Intl., Inc. KIR Class I 1993-03-23
K930383 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421 Proteins Intl., Inc. KIR Class I 1993-03-23
K930373 ONE DRAM SHELL VIAL, CATALOG #02-111 Proteins Intl., Inc. KIR Class I 1993-03-23
K930374 25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111 Proteins Intl., Inc. KIR Class I 1993-03-23
K930325 CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS Proteins Intl., Inc. KIR Class I 1993-03-23
K930366 16 X 25 MM TEST TUBE, CATALOG #01-461 Proteins Intl., Inc. KIR Class I 1993-03-23
K930415 MICROHEMATOCRIT ROTOR Fisher Scientific Co., LLC GKG Class II 1993-03-23
K930380 16 X 125 MM TEST TUBE, CATALOG #01-261 Proteins Intl., Inc. KIR Class I 1993-03-23
K930385 16 X 125 MM TEST TUBE, CATALOG #01-421 Proteins Intl., Inc. KIR Class I 1993-03-23
K930367 25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321 Proteins Intl., Inc. KIR Class I 1993-03-23
K930375 16 X 125 MM TEST TUBE, CATALOG #01-211 Proteins Intl., Inc. KIR Class I 1993-03-23
K930387 ONE DRAM SHELL VIAL, CATALOG #02-401 Proteins Intl., Inc. KIR Class I 1993-03-23
K930379 ONE DRAM SHELL VIAL, CATALOG #02-281 Proteins Intl., Inc. KIR Class I 1993-03-23

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