Hematology
4,194 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| BLOOD CELL SEPARATOR 2997 (K771258) | Intl. Business Machines | 1977-09-06 |
| TEKTALLY II (K771580) | Scientific Products | 1977-09-02 |
| PLATELET CONTROLS NORMAL & ABNORMAL (K771588) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 |
| CI-TROL COAGULATION CONTROLS II & III (K771346) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-22 |
| HISTOCHEMICAL FERRIC IRON SET (K771524) | Harleco | 1977-08-22 |
| HISTOCHEMICAL AFB DEMONSTRATION (K771390) | Harleco | 1977-08-22 |
| PLATELET COUNTER & HEMATOCRIT ACCES. (K771353) | Hycel, Inc. | 1977-08-10 |
| AUTO DIFFERENTIAL CELL COUNTER SYSTEM (K770244) | Abbott Laboratories | 1977-08-04 |
| BLOOD GROUPING SYS., BG-9 (K771098) | Technicon Instruments Corp. | 1977-08-04 |
| INCUBATOR, PORTABLE, ACT-STAT (K770914) | Thermolyne Corp. | 1977-08-04 |
| PIPETS UNIFORM DROP SIZE BOROSILICATE (K771137) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 |
| PIPETS BOROSILICATE GLASS (K771138) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 |
| RADIOMHTER OSM-2 HEMOXIMETER (K771263) | The London Co. | 1977-08-03 |
| LUMI-AGGREGOMETER (K771198) | Chrono-Log Corp. | 1977-08-02 |
| TISSUE CULTURE MEDIA W/HEPES BUFFER (K770764) | Microbiological Assoc. | 1977-07-21 |
| HEMOGLOBIN ANALYZER & PERFORM. CHECK SET (K771101) | The Dow Chemical Co. | 1977-07-21 |
| PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY (K770942) | Pharmaseal Div., Baxter Healthcare Corp. | 1977-07-21 |
| LANCER CAPILLARY BLOOD SERUM SEPARATOR (K770981) | Sherwood Medical Industries | 1977-07-11 |
| UNIPAK HEMOGLOBIN (K771090) | Harleco | 1977-07-11 |
| EMATOLOGY DILUENT RESERVOIR CLOSURE (K770980) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-07-11 |
| THROMBO SCREEN QUANTITATIVE HEPARIN ASSA (K770722) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-07-11 |
| COUNTER 700 & HC-700 HEMO 0 REF. (K771107) | Hycel, Inc. | 1977-07-11 |
| TUBE, STAIN, RETICULOCYTE, LARC (K770792) | Corning Medical & Scientific | 1977-07-05 |
| HEMOTOLOGY PRODU&TS (5 IN ALL) (K770803) | Hycel, Inc. | 1977-07-05 |
| HEMATRAK (K770680) | Geometric Data, Div. Smithkline Corp. | 1977-07-01 |
| LATELET DETERMIBATION KIT, UL 800 (K770655) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 |
| ATYPIA PROFILE MONITOR (K770550) | Geometric Data, Div. Smithkline Corp. | 1977-06-17 |
| HEMATRAK MODEL 125 (K770701) | Geometric Data, Div. Smithkline Corp. | 1977-06-03 |
| ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION (K770869) | Geometric Data, Div. Smithkline Corp. | 1977-06-02 |
| ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH (K770606) | Damon Corp. | 1977-05-06 |
| HEMALOG 8/90 (K770666) | Technicon Instruments Corp. | 1977-05-06 |
| LATELET DETERMIN. KIT, CAT NO. 2521 (K770385) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-08 |
| MNITROL HEMOTOL. REF. AND CONTROL (K770384) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-08 |
| LYMPHOCYTE TYPING, NEGATIVE CONTROL (K761008) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
| LYMPHOCYTE TYPING, POSITIVE CONTROL (K761009) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
| THROMBO-SCREEN AT-111 KIT (K770394) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-30 |
| ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) (K761289) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-28 |
| BIO-DYES FORTIFIED HEMATOLOGY STAIN (K770074) | Jack W. Kindberg | 1977-03-22 |
| BIO-DYES HEMATOLOGY PHOSPHATE (K770075) | Jack W. Kindberg | 1977-03-22 |
| THROMBO-CETIN (RISTOCETIN) (K770395) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-21 |
| LATELET, CONTROL, NORMAL & ABNORMAL (K770386) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-21 |
| RH CONTROL DILUENT (K770185) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-14 |
| ECOLYZER CARBOXIMETER (K770209) | Iadec, Inc. | 1977-03-07 |
| SIMPLATE (K761250) | General Diagnostics | 1977-03-01 |
| HEMATRAK MATURITY PROFILE OPTION (K761208) | Geometric Data, Div. Smithkline Corp. | 1977-02-28 |
| PLATELET CONTROL, NORMAL & ABNORMAL (K770095) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-02-28 |
| HPC TM (HEPARINIZED PLASMA CONTROL) (K770188) | Bio/Data Corp. | 1977-02-18 |
| COUNTER, BLOOD CELL & HEMATOCRIT (K770034) | Mallinckrodt Critical Care | 1977-02-16 |
| PLATELET-CHEX-HUMAN (K770020) | Streck Laboratories, Inc. | 1977-02-16 |
| BLOOD/FLUID WARMER MODEL DW-1000A (K770232) | Gorman Rupp Industries | 1977-02-14 |
| CAMCO R PAK-GUAIAC (K770153) | Cambridge Chemical Products, Inc. | 1977-02-08 |
| MICROSAMPLE BLOOD COLLECTION DEVICE (K761137) | Ortho Diagnostics, Inc. | 1977-02-07 |
| QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT (K761058) | Bio/Data Corp. | 1977-02-07 |
| TPC-LYOPHILIZED POOLED HUMAN PLASMA (K761091) | Bio/Data Corp. | 1977-02-01 |
| JTB 700 HEMATOLOGY ANALYZER (K761304) | J.T. Baker Chemical Co. | 1977-02-01 |
| UNIVAL CONTROL CELLS (K761284) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 |
| TERASAKI LYMPHOCYTE TRANSPORT KIT (K760952) | Dravon Medical, Inc. | 1977-01-17 |
| AGGRECETIN (K760893) | Bio/Data Corp. | 1977-01-12 |
| VERONAL BUFFER (K761171) | Bio/Data Corp. | 1977-01-10 |
| IMIDAZOLE BUFFER (0.05M) (K761175) | Bio/Data Corp. | 1977-01-10 |
| HEPARIN CONTROL PLASMA (K760918) | Hyland Therapeutic Div., Travenol Laboratories | 1977-01-10 |
| TRIS BUFFERED SALINE (K761172) | Bio/Data Corp. | 1977-01-10 |
| CALCIUM CHLORIDE (0.025M) (K761176) | Bio/Data Corp. | 1977-01-10 |
| BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (K760856) | Intl. Business Machines | 1977-01-10 |
| TRIS BUFFERED (K761173) | Bio/Data Corp. | 1977-01-10 |
| IMMU-SAL IMMUNOHEMATOLOGICAL SALINE (K761303) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 |
| WHOLE BLOOD PLATELET COUNTER -2510 (K760765) | Clay Adams, Div. Becton Dickinson & Co. | 1976-12-30 |
| QUICK CULT SLIDE TEST FECAL OCCULT BLOOD (K761232) | Laboratory Diagnostics Co., Inc. | 1976-12-21 |
| ISOTONIC DILUENT AF (K761182) | Central Labs. Assoc. MD Pathologists | 1976-12-09 |
| DONORMATIC (BLOOD COLLECTION DEVICE) (K760743) | Lifeline Instruments, Inc. | 1976-12-06 |
| AUTO-FI COAGULATION INSTRUMENT (K760594) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-11-24 |
| DOUBLE ELUTRA-PACK UNIT (K760914) | Travenol Laboratories, S.A. | 1976-11-23 |
| HA/3 HEMATOLOGY ANALYZER (K760582) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-11 |
| STERILE DISPOSABLE COTTON PLUGGED SER. (K760899) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 |
| HA/5 HEMATOLOGY ANALYZER (K760581) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 |
| UNIFORM DROP SIZE PASTEUR TYPE PIPETS (K760719) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-29 |
| PLATELET CONTROLS, NORMAL & ABNORMAL (K760549) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-08 |
| 4C ABNORMAL LOW-HIGH (8 X 6 M1) (K760682) | Coulter Electronics, Inc. | 1976-10-08 |
| BIOTROL-ABNORMAL (K760596) | Boehringer Mannheim Corp. | 1976-10-08 |
| BIOTROL-NORMAL (K760597) | Boehringer Mannheim Corp. | 1976-10-08 |
| BLOOD-SMEARING INSTRUMENT (MINIPREP TM) (K760007) | Geometric Data, Div. Smithkline Corp. | 1976-09-03 |
| HEMASTAIN FIXATIVE (K760485) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| HEMASTAIN PHOSPHATE BUFFER (K760487) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| HEMATOLOGY CONTROL (K760162) | Biological Corp. of America | 1976-08-04 |
| ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT (K760318) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-03 |
| OXIMETER, CO-, IL MODEL 282 (K760208) | Instrumentation Laboratory CO | 1976-07-26 |
| DSP - STAIN PACK (K760027) | Harleco | 1976-07-20 |
| SALINE, ISOTONIC BUFFERED, AZIDE-FREE (K760129) | Harleco | 1976-07-20 |
| HISTOCHEMICAL PAS REACTION SET (K760031) | Harleco | 1976-07-20 |
| AUTOZYME (K760123) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
| AGGREGOMETER, DUAL CHANNEL PLATELET (K760159) | Chrono-Log Corp. | 1976-07-20 |
| AUTO CELL DILUENT (K760124) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
| KIT, PLATELET AGGREGATION REAGENT (#390) (K760198) | Chrono-Log Corp. | 1976-07-19 |
| BLOOD WARMER (CODE 4R4305) (K760012) | Travenol Laboratories, S.A. | 1976-07-16 |
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