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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
50
Latest Decision
1977-10-07

Clearances · page 42 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771789 BLANKING SOLUTION HGB J.T. Baker Chemical Co. GKR Class II 1977-10-07
K771790 DETECTOTERGE AZIDE FREE J.T. Baker Chemical Co. GKL Class II 1977-10-07
K771716 CYMET-PLUS J.T. Baker Chemical Co. GKK Class II 1977-09-20
K771258 BLOOD CELL SEPARATOR 2997 Intl. Business Machines GKT Class II 1977-09-06
K771580 TEKTALLY II Scientific Products GKM Class I 1977-09-02
K771588 PLATELET CONTROLS NORMAL & ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. GJP Class II 1977-08-25
K771524 HISTOCHEMICAL FERRIC IRON SET Harleco IAE Class I 1977-08-22
K771346 CI-TROL COAGULATION CONTROLS II & III Dade, Baxter Travenol Diagnostics, Inc. GGN Class II 1977-08-22
K771390 HISTOCHEMICAL AFB DEMONSTRATION Harleco ICL Class I 1977-08-22
K771353 PLATELET COUNTER & HEMATOCRIT ACCES. Hycel, Inc. GKL Class II 1977-08-10
K771137 PIPETS UNIFORM DROP SIZE BOROSILICATE Dade, Baxter Travenol Diagnostics, Inc. GJW Class I 1977-08-04
K770244 AUTO DIFFERENTIAL CELL COUNTER SYSTEM Abbott Laboratories GKZ Class II 1977-08-04
K771098 BLOOD GROUPING SYS., BG-9 Technicon Instruments Corp. KSZ Class II 1977-08-04
K770914 INCUBATOR, PORTABLE, ACT-STAT Thermolyne Corp. KQG Class II 1977-08-04
K771138 PIPETS BOROSILICATE GLASS Dade, Baxter Travenol Diagnostics, Inc. GJW Class I 1977-08-04
K771263 RADIOMHTER OSM-2 HEMOXIMETER The London Co. GHS Class II 1977-08-03
K771198 LUMI-AGGREGOMETER Chrono-Log Corp. JBY Class II 1977-08-02
K770942 PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY Pharmaseal Div., Baxter Healthcare Corp. JBQ Class II 1977-07-21
K770764 TISSUE CULTURE MEDIA W/HEPES BUFFER Microbiological Assoc. KIT Class I 1977-07-21
K771101 HEMOGLOBIN ANALYZER & PERFORM. CHECK SET The Dow Chemical Co. GIG Class II 1977-07-21
K770722 THROMBO SCREEN QUANTITATIVE HEPARIN ASSA Bay Area Hema. Onco. Clinic. & Res. L JBR Class II 1977-07-11
K771107 COUNTER 700 & HC-700 HEMO 0 REF. Hycel, Inc. GKL Class II 1977-07-11
K770980 EMATOLOGY DILUENT RESERVOIR CLOSURE Bd Becton Dickinson Vacutainer Systems Preanalytic GHO Class I 1977-07-11
K770981 LANCER CAPILLARY BLOOD SERUM SEPARATOR Sherwood Medical Industries GIO Class I 1977-07-11
K771090 UNIPAK HEMOGLOBIN Harleco GKK Class II 1977-07-11
K770803 HEMOTOLOGY PRODU&TS (5 IN ALL) Hycel, Inc. GKK Class II 1977-07-05
K770792 TUBE, STAIN, RETICULOCYTE, LARC Corning Medical & Scientific KFC Class I 1977-07-05
K770680 HEMATRAK Geometric Data, Div. Smithkline Corp. GKZ Class II 1977-07-01
K770655 LATELET DETERMIBATION KIT, UL 800 Bd Becton Dickinson Vacutainer Systems Preanalytic GJP Class II 1977-06-24
K770550 ATYPIA PROFILE MONITOR Geometric Data, Div. Smithkline Corp. GKZ Class II 1977-06-17
K770701 HEMATRAK MODEL 125 Geometric Data, Div. Smithkline Corp. GKZ Class II 1977-06-03
K770869 ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION Geometric Data, Div. Smithkline Corp. GKZ Class II 1977-06-02
K770606 ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH Damon Corp. JPA Class II 1977-05-06
K770666 HEMALOG 8/90 Technicon Instruments Corp. GKL Class II 1977-05-06
K770385 LATELET DETERMIN. KIT, CAT NO. 2521 Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1977-04-08
K770384 MNITROL HEMOTOL. REF. AND CONTROL Bd Becton Dickinson Vacutainer Systems Preanalytic JPK Class II 1977-04-08
K761008 LYMPHOCYTE TYPING, NEGATIVE CONTROL Hyland Therapeutic Div., Travenol Laboratories LGO Class I 1977-04-06
K761009 LYMPHOCYTE TYPING, POSITIVE CONTROL Hyland Therapeutic Div., Travenol Laboratories LGO Class I 1977-04-06
K770394 THROMBO-SCREEN AT-111 KIT Bay Area Hema. Onco. Clinic. & Res. L JBQ Class II 1977-03-30
K761289 ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1977-03-28
K770074 BIO-DYES FORTIFIED HEMATOLOGY STAIN Jack W. Kindberg IAF Class I 1977-03-22
K770075 BIO-DYES HEMATOLOGY PHOSPHATE Jack W. Kindberg IAF Class I 1977-03-22
K770395 THROMBO-CETIN (RISTOCETIN) Bay Area Hema. Onco. Clinic. & Res. L JOZ Class II 1977-03-21
K770386 LATELET, CONTROL, NORMAL & ABNORMAL Bd Becton Dickinson Vacutainer Systems Preanalytic JPK Class II 1977-03-21
K770185 RH CONTROL DILUENT Bd Becton Dickinson Vacutainer Systems Preanalytic KSZ Class II 1977-03-14
K770209 ECOLYZER CARBOXIMETER Iadec, Inc. GHS Class II 1977-03-07
K761250 SIMPLATE General Diagnostics JCA Class II 1977-03-01
K770095 PLATELET CONTROL, NORMAL & ABNORMAL Bd Becton Dickinson Vacutainer Systems Preanalytic JPK Class II 1977-02-28
K761208 HEMATRAK MATURITY PROFILE OPTION Geometric Data, Div. Smithkline Corp. GKZ Class II 1977-02-28
K770188 HPC TM (HEPARINIZED PLASMA CONTROL) Bio/Data Corp. GGC Class II 1977-02-18
K770034 COUNTER, BLOOD CELL & HEMATOCRIT Mallinckrodt Critical Care GKL Class II 1977-02-16
K770020 PLATELET-CHEX-HUMAN Streck Laboratories, Inc. JPK Class II 1977-02-16
K770232 BLOOD/FLUID WARMER MODEL DW-1000A Gorman Rupp Industries BSB Class II 1977-02-14
K770153 CAMCO R PAK-GUAIAC Cambridge Chemical Products, Inc. KHE Class II 1977-02-08
K761137 MICROSAMPLE BLOOD COLLECTION DEVICE Ortho Diagnostics, Inc. GKH Class I 1977-02-07
K761058 QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT Bio/Data Corp. GGP Class II 1977-02-07
K761304 JTB 700 HEMATOLOGY ANALYZER J.T. Baker Chemical Co. JPJ Class II 1977-02-01
K761091 TPC-LYOPHILIZED POOLED HUMAN PLASMA Bio/Data Corp. JPA Class II 1977-02-01
K761284 UNIVAL CONTROL CELLS Dade, Baxter Travenol Diagnostics, Inc. KSF Class II 1977-01-25
K760952 TERASAKI LYMPHOCYTE TRANSPORT KIT Dravon Medical, Inc. KSR Class II 1977-01-17
K760893 AGGRECETIN Bio/Data Corp. JOZ Class II 1977-01-12
K760856 BLOOD CELL PROCESSOR MODEL 2 IBM 2991 Intl. Business Machines GKT Class II 1977-01-10
K761172 TRIS BUFFERED SALINE Bio/Data Corp. JPA Class II 1977-01-10
K761173 TRIS BUFFERED Bio/Data Corp. JPA Class II 1977-01-10
K761171 VERONAL BUFFER Bio/Data Corp. JPA Class II 1977-01-10
K761175 IMIDAZOLE BUFFER (0.05M) Bio/Data Corp. JPA Class II 1977-01-10
K761176 CALCIUM CHLORIDE (0.025M) Bio/Data Corp. JPA Class II 1977-01-10
K760918 HEPARIN CONTROL PLASMA Hyland Therapeutic Div., Travenol Laboratories GFO Class II 1977-01-10
K760765 WHOLE BLOOD PLATELET COUNTER -2510 Clay Adams, Div. Becton Dickinson & Co. GKL Class II 1976-12-30
K761303 IMMU-SAL IMMUNOHEMATOLOGICAL SALINE Dade, Baxter Travenol Diagnostics, Inc. KSS Class I 1976-12-30
K761232 QUICK CULT SLIDE TEST FECAL OCCULT BLOOD Laboratory Diagnostics Co., Inc. KHE Class II 1976-12-21
K761182 ISOTONIC DILUENT AF Central Labs. Assoc. MD Pathologists GGK Class I 1976-12-09
K760743 DONORMATIC (BLOOD COLLECTION DEVICE) Lifeline Instruments, Inc. KSQ Class I 1976-12-06
K760594 AUTO-FI COAGULATION INSTRUMENT Dade, Baxter Travenol Diagnostics, Inc. JPA Class II 1976-11-24
K760914 DOUBLE ELUTRA-PACK UNIT Travenol Laboratories, S.A. KSW Class II 1976-11-23
K760582 HA/3 HEMATOLOGY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1976-11-11
K760581 HA/5 HEMATOLOGY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1976-11-09
K760899 STERILE DISPOSABLE COTTON PLUGGED SER. Bd Becton Dickinson Vacutainer Systems Preanalytic GJW Class I 1976-11-09
K760719 UNIFORM DROP SIZE PASTEUR TYPE PIPETS Dade, Baxter Travenol Diagnostics, Inc. GJG Class I 1976-10-29
K760682 4C ABNORMAL LOW-HIGH (8 X 6 M1) Coulter Electronics, Inc. JPK Class II 1976-10-08
K760596 BIOTROL-ABNORMAL Boehringer Mannheim Corp. JPK Class II 1976-10-08
K760549 PLATELET CONTROLS, NORMAL & ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. JPK Class II 1976-10-08
K760597 BIOTROL-NORMAL Boehringer Mannheim Corp. JPK Class II 1976-10-08
K760007 BLOOD-SMEARING INSTRUMENT (MINIPREP TM) Geometric Data, Div. Smithkline Corp. GKJ Class I 1976-09-03
K760487 HEMASTAIN PHOSPHATE BUFFER Geometric Data, Div. Smithkline Corp. KQC Class I 1976-08-30
K760485 HEMASTAIN FIXATIVE Geometric Data, Div. Smithkline Corp. KQC Class I 1976-08-30
K760162 HEMATOLOGY CONTROL Biological Corp. of America JPK Class II 1976-08-04
K760318 ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT Dade, Baxter Travenol Diagnostics, Inc. GFO Class II 1976-08-03
K760208 OXIMETER, CO-, IL MODEL 282 Instrumentation Laboratory CO KHG Class II 1976-07-26
K760031 HISTOCHEMICAL PAS REACTION SET Harleco HZT Class I 1976-07-20
K760129 SALINE, ISOTONIC BUFFERED, AZIDE-FREE Harleco GIF Class I 1976-07-20
K760159 AGGREGOMETER, DUAL CHANNEL PLATELET Chrono-Log Corp. JBX Class II 1976-07-20
K760124 AUTO CELL DILUENT Bd Becton Dickinson Vacutainer Systems Preanalytic GIF Class I 1976-07-20
K760027 DSP - STAIN PACK Harleco IAF Class I 1976-07-20
K760123 AUTOZYME Bd Becton Dickinson Vacutainer Systems Preanalytic KSK Class II 1976-07-20
K760198 KIT, PLATELET AGGREGATION REAGENT (#390) Chrono-Log Corp. GHR Class II 1976-07-19
K760012 BLOOD WARMER (CODE 4R4305) Travenol Laboratories, S.A. BSB Class II 1976-07-16

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