Hematology
4,194 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| ANTITHROMBIN III ASSAY (K781480) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-08 |
| TRANSFER PAK 4R 9006 (K781811) | Travenol Laboratories, S.A. | 1978-11-08 |
| GLYCOHEMOGLOBIN-SKREEN TEST KIT (K780819) | Eppendorf-Brinkmann, Inc. | 1978-11-07 |
| TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN (K780573) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-07 |
| HEMOGLOBIN, TESTING SYSTEM (K781851) | Isolab, Inc. | 1978-11-07 |
| HEMO-W SYSTEM (K781628) | Coulter Electronics, Inc. | 1978-10-27 |
| BUFFER, COLLAGEN REAGENT AND DILUENT (K781710) | Diagnostica, Inc. | 1978-10-24 |
| NORMAL HEMATOLOGY CONTROL UNASSAYED (K781572) | Ortho Diagnostics, Inc. | 1978-10-17 |
| ABNORMAL HEMATOLOGY CONTROL UNASSAYED (K781573) | Ortho Diagnostics, Inc. | 1978-10-17 |
| TEKNI-CAL (K781601) | Streck Laboratories, Inc. | 1978-10-10 |
| HEMATOXYLIN STAIN HARRIS (K781585) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STAIN EA-36 (K781582) | Bioscientific | 1978-10-10 |
| GRAM STAIN KIT (K781584) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STIAN OG-6 (K781588) | Bioscientific | 1978-10-10 |
| HEMATOLOGY STAIN PACK (K781587) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STAIN :EA-50: (K781583) | Bioscientific | 1978-10-10 |
| ACID FAST KIT (K781643) | Bioscientific | 1978-10-03 |
| TEST SYSTEM TISSUE CELL CULTURE SLIDE (K781516) | Zeus Scientific, Inc. | 1978-09-27 |
| SPECTRASCAN (K781103) | Medishield, Inc. | 1978-09-27 |
| HEMOGLOBINOMETER MODEL 720 B (K781361) | Innovative Medical Systems, Inc. | 1978-09-14 |
| QUANTICEL-HRP (K781247) | Bhp Diagnostix, Inc. | 1978-09-14 |
| ORTHO LOW IONIC SOLUTION (K781435) | Ortho Diagnostics, Inc. | 1978-09-14 |
| HEMAC LASER HEMATOLOGY SYSTEM (K781146) | Ortho Instruments | 1978-09-14 |
| EM-V (K781397) | Biological Corp. of America | 1978-09-14 |
| MYCOPLASMA HYORHINIS (BTS-7) (K781390) | Flow Laboratories, Inc. | 1978-09-01 |
| LIPOPROTEIN STAIN (K781122) | Electrophoresis Corp. of America | 1978-08-31 |
| CAMCO QUIK STAIN II (K781347) | Cambridge Chemical Products, Inc. | 1978-08-21 |
| WRIGHT RAPID STAIN (K781384) | Mfg Chemists, Inc. | 1978-08-21 |
| PBS FOR FA (46-991-49) (K781391) | Flow Laboratories, Inc. | 1978-08-21 |
| CUTTER/COMPUR MINI CENTRIFUGE (K781059) | Cutter Laboratories, Inc. | 1978-08-14 |
| DROPPER, SOLUTION TRICHROME, CEPTI-SEAL (K781062) | Marion Laboratories, Inc. | 1978-08-14 |
| PC-CALIBRATOR (K781133) | Streck Laboratories, Inc. | 1978-08-14 |
| CELL CULTURE LINES (K780869) | Bioassay Systems Research Corp. | 1978-08-14 |
| HEMOLYSE (K781121) | Electrophoresis Corp. of America | 1978-08-14 |
| DROPPERS, SOLUTION, IODINE (K781061) | Marion Laboratories, Inc. | 1978-08-14 |
| ECA HEME BUFFER (K781119) | Electrophoresis Corp. of America | 1978-08-14 |
| PLASMA COAGULATION CONT., ABNORMAL (K781104) | Ortho Diagnostics, Inc. | 1978-08-10 |
| ANTITHROMBIN III SERUM, ANTI-HUMAN (K781026) | Icl Scientific | 1978-08-10 |
| CONTROL, HEMATOLOGY, CH-60 (K781077) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-07-27 |
| PLATELET CONTROL (K780980) | Bhp Diagnostix, Inc. | 1978-07-27 |
| ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (K780946) | Hycel, Inc. | 1978-07-27 |
| AUTOMATED ENZYME (K780962) | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
| FECATEST (K780564) | Otto C. Watzka | 1978-06-30 |
| ISOTONIC DILUENT (K781008) | Mallinckrodt Critical Care | 1978-06-28 |
| SYSMEX PLATELET COUNTER, PL-110 (K780911) | Toa Medical Electronics USA, Inc. | 1978-06-28 |
| SYSTEM AUTO. BLOOD CELL COUNTER CC-110 (K780910) | Toa Medical Electronics USA, Inc. | 1978-06-28 |
| SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 (K780909) | Toa Medical Electronics USA, Inc. | 1978-06-28 |
| SYSING AND HEMOGLOBIN REAGENT (K780829) | Harleco | 1978-06-22 |
| ARANTROL (K780835) | Aranco Diagnostic Laboratories, Inc. | 1978-06-22 |
| ISOTONIC BUFFERED SALINE (K780830) | Harleco | 1978-06-14 |
| MLA ELECTRA 750 COAGULATION TIMER (K780810) | Medical Laboratory Automation Systems, Inc. | 1978-06-14 |
| CRYOCYTE PACK (K780354) | Travenol Laboratories, S.A. | 1978-06-14 |
| PLATELET CONTROL (K780714) | Bhp Diagnostix, Inc. | 1978-06-06 |
| RECAP (K780665) | Bca Biological Corp. of America | 1978-06-06 |
| HBF-QUIPLATE METHODOLOGY (K780807) | Helena Laboratories | 1978-06-02 |
| PLATELETS/CU MM (K780577) | Geometric Data, Div. Smithkline Corp. | 1978-05-19 |
| MICROCELL COUNTER MODEL CC-108 (K780224) | Toa Medical Electronics USA, Inc. | 1978-05-19 |
| HEMO FEC (K780214) | Boehringer Mannheim Corp. | 1978-05-03 |
| LOW IIONIC STRENGTH SOLUTION (K780413) | Pfizer, Inc. | 1978-04-24 |
| QUALITY CONTROL SYSTEM, SPECTRA (K780097) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
| SPECT RIM (LISS) (K780556) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
| ATROXIN (K780355) | Sigma Chemical Co. | 1978-04-18 |
| SOLUBLE COLLAGEN (K780285) | General Diagnostics | 1978-03-30 |
| PLATELET ROTATOR (K780189) | Travenol Laboratories, S.A. | 1978-03-30 |
| REDI-DISC HEMOGLOBIN GEL TUBE KIT (K780163) | Miles Laboratories, Inc. | 1978-03-27 |
| THROMBOPLASTIN DRIED (K780203) | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-27 |
| CELL-CHEX (K780140) | Streck Laboratories, Inc. | 1978-03-27 |
| CELL (K780305) | Dynatech Laboratories, Inc. | 1978-03-27 |
| MIF PROCEDURE KIT (K780346) | Marion Laboratories, Inc. | 1978-03-22 |
| DISPOSABLE CONTROLLED DROP PASTEUR PIPET (K780237) | Owens-Illinois, Inc. | 1978-03-09 |
| PLATELET AGGREGATING REAGENTS (K780047) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 |
| IMMUFUGE DISP. LINER (K780281) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 |
| LAS-R HUMAN ANTITHROMBIN III TEST (K772328) | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 |
| HEMATOLOGY REFERENCE CONTROLS (K772195) | R&D Systems, Inc. | 1978-02-03 |
| ANTITHROMBIN III ASSAY (K780002) | Ortho Diagnostics, Inc. | 1978-01-31 |
| TQC CALIBRATION REFERENCE FOR PLATELETS (K770143) | Technicon Instruments Corp. | 1978-01-30 |
| ANTITHROMBIN III RIA (K780012) | Ria Diagnostics | 1978-01-20 |
| GUINEA PIG WHOLE SERUM (K780009) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| RE-CELL SLIDE RECAP (K772139) | Geometric Data, Div. Smithkline Corp. | 1978-01-05 |
| SCANNING SYS., AUTO. COMP., ACS1000 (K772140) | Honeywell, Inc. | 1977-12-05 |
| PLATELET KIT (K772105) | Streck Laboratories, Inc. | 1977-11-30 |
| HEMATOLOGY REFERENCE CONTROL (K771753) | Coulter Electronics, Inc. | 1977-11-28 |
| THROMBO-SCREEN PLATELET ADHESION (K771678) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-11-22 |
| LATELET RETENTION COLUMN (K771523) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-22 |
| MYCOPLASMA DETECTION KIT (K771867) | Bioassay Systems Research Corp. | 1977-11-17 |
| COUNTER MODEL S PLUS BLOOD CELL COUNTER (K771512) | Coulter Electronics, Inc. | 1977-11-09 |
| DIAG. KIT FOR TOTAL ANTITHROMBIN III (K771669) | Abbott Laboratories | 1977-11-09 |
| LEWIS BLOOD GROUP SUBSTANCE (K771487) | Ortho Diagnostics, Inc. | 1977-11-08 |
| P1 BLOOD GROUP SUBSTANCE (K771488) | Ortho Diagnostics, Inc. | 1977-11-08 |
| AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 (K771728) | Technicon Instruments Corp. | 1977-11-07 |
| REAGENT CONFIDENCE SERA (K771814) | Ortho Diagnostics, Inc. | 1977-11-07 |
| PONCEAU S CONCENTRATE (K771777) | Sigma Chemical Co. | 1977-10-25 |
| AUTOMATED SLIDE SPINNER (K771898) | Dynatech Cryomedical Co. | 1977-10-18 |
| HEMATRAK RBC MORPHOLOGY (K761207) | Geometric Data, Div. Smithkline Corp. | 1977-10-18 |
| HEMOGLOBIN A2 TESTING SYSTEM (K771649) | Isolab, Inc. | 1977-10-07 |
| DETECTOTERGE AZIDE FREE (K771790) | J.T. Baker Chemical Co. | 1977-10-07 |
| BLANKING SOLUTION HGB (K771789) | J.T. Baker Chemical Co. | 1977-10-07 |
| CYMET-AUTOMATED (K771788) | J.T. Baker Chemical Co. | 1977-10-07 |
| AZIDE FREE BLOOD DILUTING REAGENT (K771787) | J.T. Baker Chemical Co. | 1977-10-07 |
| CYMET-PLUS (K771716) | J.T. Baker Chemical Co. | 1977-09-20 |
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