Hematology
4,194 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| FISHER DIAGNOSTICS HEMATOLOGY CONTROLS (K792055) | Fisher Scientific Co., LLC | 1979-11-05 |
| MONOJECT SICKLE CELL KIT (K791971) | Sherwood Medical Co. | 1979-11-05 |
| LANCER COAGENT PT KIT (K792031) | Sherwood Medical Co. | 1979-11-05 |
| VOLU-SOL STAT STAIN (K792017) | Volu Sol Medical Industries | 1979-10-30 |
| COULTER DIFF3 SYS. (COULTER #7400003) (K791903) | Coulter Electronics, Inc. | 1979-10-30 |
| EMPTY TRANSFER BAG (K791673) | Delmed, Inc. | 1979-10-23 |
| A-GENT GLYCOSPEC (K791642) | Abbott Laboratories | 1979-10-17 |
| IMPROVED GRAM STAIN REAGENTS (K791711) | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 |
| WRIGHTS RAPID STAIN (K791929) | Mcb Manufacturing Chemists, Inc. | 1979-10-11 |
| ORTHO ANTIBODY ENHANCEMENT SOLUTION (K791791) | Ortho Diagnostics, Inc. | 1979-10-11 |
| COUNTER-CHECK PLUS NORMAL, HIGH ABN. (K791772) | Diagnostic Technology, Inc. | 1979-10-11 |
| COUNTER-CHECK PLUS (K791750) | Diagnostic Technology, Inc. | 1979-10-11 |
| FACTOR VII DEFICIENT PLASMA (K791794) | Sigma Chemical Co. | 1979-10-01 |
| FAST FLOW #60310 (K791365) | Hi Chem, Inc. | 1979-09-27 |
| ROYCO MODEL 371 SUPER DILUTOR (K791644) | Royco Instruments | 1979-09-19 |
| ELVI 840 AGGREGOMETER (K791577) | Volu Sol Medical Industries | 1979-09-17 |
| ELVI 818 DIGICLOT MULTISCAN (K791586) | Volu Sol Medical Industries | 1979-09-17 |
| ELVI 810 CLOTSCANNER (K791587) | Volu Sol Medical Industries | 1979-09-17 |
| FLU-VEN TK-2 (K791130) | Venospital, Inc. | 1979-09-04 |
| HEMATRAK ABNORMAL RECOGNITION (K791041) | Geometric Data, Div. Smithkline Corp. | 1979-09-04 |
| FLU VEN TR-1 (K791131) | Venospital, Inc. | 1979-09-04 |
| FIBRO-TEC TEST KIT (K791358) | Calbiochem-Behring Corp. | 1979-09-04 |
| MODEL 114 TREONIC H150 HAEMOHEATER (K790936) | Vickers America Medical Corp. | 1979-09-04 |
| GLUCOHEMOGLOBIN CONTROL (K791428) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-08-22 |
| STERILE, DISPOSABLE CENTRIFUGE BOWL (K791106) | Travenol Laboratories, S.A. | 1979-08-10 |
| STAT DIFF STAIN (K791007) | Bioscientific | 1979-08-03 |
| HLA CONTROL SERA (K791118) | Calbiochem-Behring Corp. | 1979-08-03 |
| BECKMAN B-4 TEB BUFFER KIT (K791290) | Beckman Instruments, Inc. | 1979-08-03 |
| ECA (SPECIAL) HEME BUFFER (K791008) | Electrophoresis Corp. of America | 1979-08-03 |
| PARA-8 (K791228) | Streck Laboratories, Inc. | 1979-08-03 |
| PARA-7 (K791227) | Streck Laboratories, Inc. | 1979-08-03 |
| PLATELET-CHEX PLUS (K791226) | Streck Laboratories, Inc. | 1979-08-03 |
| PROTHROMBIN REFERENCE PLASMA (HUMAN) (K791022) | Pacific Hemostasis | 1979-07-24 |
| HEMATRAK MODEL 480 (K790816) | Geometric Data, Div. Smithkline Corp. | 1979-07-17 |
| CONTEXT FILTER (K791108) | Geometric Data, Div. Smithkline Corp. | 1979-07-17 |
| SICKLE-CELL F TEST (K791143) | Isolab, Inc. | 1979-07-17 |
| 120 WELL HISTO-PLATE (K790958) | Dynatech Laboratories, Inc. | 1979-06-28 |
| CITRATE AGAR GEL AND BUFFER SET (K790944) | Corning Medical & Scientific | 1979-06-28 |
| LYOPHILIZED G-HB QUIK COLUMN CONTROL (K791135) | Helena Laboratories | 1979-06-28 |
| SYNALON ROLLER BOTTLE (K791049) | Dynatech Laboratories, Inc. | 1979-06-28 |
| LOW IONIC STRENGTH SOLUTION (LISS) (K791113) | Hyland Therapeutic Div., Travenol Laboratories | 1979-06-28 |
| PROTHROMBIN FREE BEEF PLASMA (PFB) (K791023) | Pacific Hemostasis | 1979-06-28 |
| LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT (K791103) | Leeco Diagnostics, Inc. | 1979-06-28 |
| TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (K790943) | Corning Medical & Scientific | 1979-06-22 |
| HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL (K791030) | Beckman Instruments, Inc. | 1979-06-22 |
| LO-ION (K790973) | Gamma Biologicals, Inc. | 1979-06-15 |
| COAGULATION ARP (K790826) | Helena Laboratories | 1979-05-31 |
| TERUMO IMUGARD (K790105) | Terumo America, Inc. | 1979-05-24 |
| DADE LOW IONIC STRENGTH SOLUITION (LISS) (K790776) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
| IMMU-TEK AUTOMATIC CENTRIFUGE (K790767) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
| TEST CELLS (K790249) | Hyland Therapeutic Div., Travenol Laboratories | 1979-05-16 |
| ELDONCARD (K790282) | Nordisk Infuser System | 1979-05-04 |
| BETA/PAK (K790769) | Bio/Data Corp. | 1979-05-03 |
| QUIK-STAIN (K790571) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-04-23 |
| QUIK COLUMN METHODOLOGY (K790583) | Helena Laboratories | 1979-04-23 |
| HEMOGLOBIN CONTROLS (K790457) | Data Medical Associates, Inc. | 1979-04-04 |
| HCP-7 (K790415) | Bioscientific | 1979-04-04 |
| ISOTONIC DILUENT (K790442) | Royco Instruments | 1979-04-04 |
| FACTOR V DEFICIENT (K790423) | Sigma Chemical Co. | 1979-04-04 |
| HEMATROL S HEMATOLOGY CONTROLS (K790525) | Fisher Scientific Co., LLC | 1979-04-03 |
| LISS REAGENT (K790498) | Fisher Scientific Co., LLC | 1979-04-03 |
| ACTIVATOR (K790346) | Tri-Med, Inc. | 1979-03-21 |
| HEMOGLOBIN CONTROLS (K790310) | Electrophoresis Corp. | 1979-03-21 |
| COAG-A-MATE 2001 (K790323) | General Diagnostics | 1979-03-21 |
| DEHYDROGENOSE, GLUCOSE PHOSPHATE (K790211) | Sigma Chemical Co. | 1979-03-15 |
| PLASMA, STANDARDIZED NORMAL (K790204) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-03-12 |
| PHYTOHAEMAGGLUTININ (K790239) | Pharmacia Fine Chemicals | 1979-03-08 |
| FLUID, RHEMOX W LYSING (K790029) | Sysmex Corp. | 1979-02-26 |
| DETERMINATION OF ANTITHROMBIN III, 885 (K790090) | Sigma Chemical Co. | 1979-02-26 |
| STAIN, HEMASTAIN RETIC (K790042) | Geometric Data, Div. Smithkline Corp. | 1979-02-15 |
| HEPARIN ASSAY (K781479) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 |
| DILUENT, CELLENT BLOOD (K790028) | Sysmex Corp. | 1979-02-15 |
| PRESSURIZER, EXETER CEMENT (K781792) | Howmedica Corp. | 1979-02-08 |
| FLUID, RHEMOX-HB LYSING (K790030) | Sysmex Corp. | 1979-02-08 |
| ANALYZER, MODEL CC-720 (K790026) | Sysmex Corp. | 1979-02-08 |
| G-HB QUIK COLUMN CONTROL (K790046) | Helena Laboratories | 1979-01-26 |
| FILTER, EYRPUR DISPOSABLE LEUKOCITE (K781803) | Metrix Teknika, Inc. | 1979-01-17 |
| REAGENT, LYSING AND HEMOGLOBIN (K782098) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-01-17 |
| COUNTER CHECK, H001, H002, H003 (K790025) | Diagnostic Technology, Inc. | 1979-01-17 |
| HEPARSORB (K781781) | General Diagnostics | 1979-01-10 |
| BLOOD, HEMATOLOGY REFERENCE CONTROL (K781969) | Coulter Electronics, Inc. | 1979-01-03 |
| PRINTER, TEK PRO TEK TALLY II (K782050) | Tekpro | 1979-01-03 |
| HYCEL COUNTER 222 (K782101) | Hycel, Inc. | 1979-01-03 |
| HYCEL COUNTER 211 (K782102) | Hycel, Inc. | 1979-01-03 |
| HYCEL COUNTER 333 (K782100) | Hycel, Inc. | 1979-01-03 |
| BLOOD GROUP SUBSTANCE A (K781862) | North American Biologicals, Inc. | 1978-12-20 |
| COLUMN TEST, HEMOGLOBIN A (K781948) | Bio-Rad | 1978-12-20 |
| STAIN KIT FOR CELL CULTURES (30-100-00) (K781875) | Flow Laboratories, Inc. | 1978-12-20 |
| MYCOPLASMA ARGININI FITC (30-403-41) (K781874) | Flow Laboratories, Inc. | 1978-12-20 |
| BLOOD GROUP SUBSTANCE B (K781895) | North American Biologicals, Inc. | 1978-12-20 |
| BLOOD GROUP SUBSTANCE A,B (K781896) | North American Biologicals, Inc. | 1978-12-20 |
| COLLAGENREAGENT HORM (K781693) | Hormon-Chemie Munchem Gmch | 1978-12-07 |
| ASSAY, CHROMOGENIC ANTITHROMBIN III (K781860) | Ortho Diagnostics, Inc. | 1978-12-04 |
| ASSAY KIT, THROMBO-SCREEN (K781880) | Pacific Hemostasis | 1978-12-04 |
| REAGENT, FIREFLY #395 (K781807) | Chrono-Log Corp. | 1978-11-22 |
| HEMACHECK (K781562) | Vickers America Medical Corp. | 1978-11-15 |
| PIPETTES, PLASTIC DISPOSABLE (K781891) | Hillwood Corp. | 1978-11-15 |
| QUANTICEL HHR # L500 AND L501 (K781786) | Bhp Diagnostix, Inc. | 1978-11-15 |
| QUANTICEL HHR, L531 AND L532 (K781745) | Bhp Diagnostix, Inc. | 1978-11-15 |
| SULFATE, FIBRIQUIK PROTAMINE (K781814) | General Diagnostics | 1978-11-08 |
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