Hematology
4,194 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| ISOPROPANOL HEMOGLOBIN STABILITY TEST (K822123) | Helena Laboratories | 1982-08-05 |
| VOLU-SOL ORANGE G-6(GILLS-MOD (K822038) | Volu Sol Medical Industries | 1982-08-03 |
| VOLU-SOL GILLS EA (K822035) | Volu Sol Medical Industries | 1982-08-03 |
| HAEM-C PLUS BLOOD REFERENCE CONTROLS (K821956) | Baker Instructions Corp. | 1982-07-30 |
| SERALYZER HEMOGLOBIN REAGENT STRIPS (K822044) | Miles Laboratories, Inc. | 1982-07-30 |
| SERALYZER HEMOGLOBIN CALIBRATORS (K822046) | Miles Laboratories, Inc. | 1982-07-30 |
| SERALYZER HEMOGLOBIN TEST MODULE (K822045) | Miles Laboratories, Inc. | 1982-07-30 |
| POWDERED RPMI-1603 MEDIUM (K821918) | Dutchland Laboratories, Inc. | 1982-07-27 |
| BME AUTOCLAVABLE MEDIUM (K821915) | Dutchland Laboratories, Inc. | 1982-07-27 |
| MCCOY'S POWDER MEDIUM 5A SUSPENSION (K821912) | Dutchland Laboratories, Inc. | 1982-07-27 |
| COON'S F-12 POWDER MEDIUM (K821914) | Dutchland Laboratories, Inc. | 1982-07-27 |
| S-MEM-JOKLIK'S POWDER (K821911) | Dutchland Laboratories, Inc. | 1982-07-27 |
| ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (K821913) | Dutchland Laboratories, Inc. | 1982-07-27 |
| EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. (K821963) | Intl. Immunoassay Laboratories, Inc. | 1982-07-27 |
| IMPROVED MEM-RICHTER'S POWDER MODIF. (K821916) | Dutchland Laboratories, Inc. | 1982-07-27 |
| POWDERED RPMI-1634 MEDIUM (K821919) | Dutchland Laboratories, Inc. | 1982-07-27 |
| WAYMOUTH'S POWDER MEDIUM (K821917) | Dutchland Laboratories, Inc. | 1982-07-27 |
| GRAMSTAIN SET (K821977) | Granite Diagnostics, Inc. | 1982-07-22 |
| ELVI BICLOT 816 (K812906) | Volu Sol Medical Industries | 1982-07-22 |
| ORTHO SPECTRUM III & ORTHO-MUNE OK (K820643) | Ortho Diagnostic Systems, Inc. | 1982-07-14 |
| SYSMEX CC-800 (K821575) | Sysmex/Toa Medical Electronics, Inc. | 1982-07-02 |
| FLEET DETECTATEST (K812728) | C.B. Fleet Co., Inc. | 1982-07-02 |
| QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL (K820630) | Isolab, Inc. | 1982-06-25 |
| HEMOGLOBIN REAGENT (K821658) | Anco Medical Reagents & Assoc. | 1982-06-25 |
| PENETRAK TM (K821186) | Syva Co. | 1982-06-25 |
| REMOVAWELL TISSUE CULTURE PLATE W/LID (K821687) | Dynatech Corp. | 1982-06-24 |
| REAGENT FOR COULTER COUNTER MODEL 5+11 (K821683) | Fisher Scientific Co., LLC | 1982-06-24 |
| HEMATOXYLIN I (K821533) | Volu Sol Medical Industries | 1982-06-10 |
| HEMATOXYLIN II (K821540) | Volu Sol Medical Industries | 1982-06-10 |
| HEMATOXYLIN III (K821541) | Volu Sol Medical Industries | 1982-06-10 |
| EOSIN Y SOLUTIN, AGUEOUS (K821574) | Sigma Chemical Co. | 1982-06-10 |
| EOSIN Y SOLUTION ALCHOLIC (K821573) | Sigma Chemical Co. | 1982-06-09 |
| IRIS URINE STAIN (K821503) | Intl. Remote Imaging Systems | 1982-06-03 |
| GLYCO-GEL TEST KIT (K821360) | Pierce Chemical Co. | 1982-06-02 |
| RETIC SET (K821318) | R&D Systems, Inc. | 1982-06-02 |
| HEMATOXYLIN STAIN (K821320) | Sigma Chemical Co. | 1982-06-02 |
| HEMACOUNT WRIGHTS STAIN PACK II #55952 (K821457) | Accra Laboratories, Inc. | 1982-06-01 |
| PLATELET AGGREGATION PROFILER #PAP-4 (K821005) | Bio/Data Corp. | 1982-06-01 |
| CC-700 SEVEN PARAMETER, AUTOMATED HEMAA (K821238) | Dysmex | 1982-05-28 |
| FAST VIOLET B (K821038) | Dms Laboratories | 1982-05-27 |
| HEMOGLOBIN REAGENT SET (K821202) | Omega Medical Electronics | 1982-05-24 |
| HEMATALL-C PLUS HEMATOLOGY CONTROLS (K820731) | Fisher Scientific Co., LLC | 1982-05-12 |
| GAMMA FETAL BLEED SCREENING TEST (K820647) | Gamma Biologicals, Inc. | 1982-05-12 |
| SEPCOR UNIT COLLECTION MONITOR (K820712) | Separation Science Corp. | 1982-05-07 |
| HEMATOXYLIN SOLUTION (K821062) | Sigma Chemical Co. | 1982-04-29 |
| AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR (K820396) | Pheragen Technology Corp. | 1982-04-27 |
| ALUMINA SILICA-ACTIVATED PARTIAL THROM (K820835) | Hyland Therapeutic Div., Travenol Laboratories | 1982-04-26 |
| HAMS F-10 POWDERED MEDIUM (K820922) | Dutchland Laboratories, Inc. | 1982-04-21 |
| EARLE'S-199 POWDERED MEDIUM (K820919) | Dutchland Laboratories, Inc. | 1982-04-21 |
| HANK'S 199 POWDERED MEDIUM (K820931) | Dutchland Laboratories, Inc. | 1982-04-21 |
| H - BME POWDERED MEDIUM (K820925) | Dutchland Laboratories, Inc. | 1982-04-21 |
| D-MEM-LOW GLUCOSE-POWDERED MEDIUM (K820921) | Dutchland Laboratories, Inc. | 1982-04-21 |
| MEM AUTOCLAVABLE MEDIUM (K820915) | Dutchland Laboratories, Inc. | 1982-04-21 |
| EBS POWDER (K820928) | Dutchland Laboratories, Inc. | 1982-04-21 |
| DULBECCO'S PBS POWDER (K820923) | Dutchland Laboratories, Inc. | 1982-04-21 |
| D-MEM-HIGH GLUCOSE-POWDERED MEDIUM (K820916) | Dutchland Laboratories, Inc. | 1982-04-21 |
| EMEM POWERED MEDIUM (K820914) | Dutchland Laboratories, Inc. | 1982-04-21 |
| MCCOY'S 5A POWDERED MEDIUM (K820920) | Dutchland Laboratories, Inc. | 1982-04-21 |
| L-15 POWDERED MEDIUM (K820917) | Dutchland Laboratories, Inc. | 1982-04-21 |
| FISCHER'S POWDERED MEDIUM (K820930) | Dutchland Laboratories, Inc. | 1982-04-21 |
| HMEM POWDERED MEDIUM (K820918) | Dutchland Laboratories, Inc. | 1982-04-21 |
| E-BME POWDERED MEDIUM (K820926) | Dutchland Laboratories, Inc. | 1982-04-21 |
| HAMS F-12 POWDERED MEDIUM (K820924) | Dutchland Laboratories, Inc. | 1982-04-21 |
| HBS POWDER (K820927) | Dutchland Laboratories, Inc. | 1982-04-21 |
| RPMI-164POWDERED MEDIUM (K820929) | Dutchland Laboratories, Inc. | 1982-04-21 |
| ALPHA PLASMA TRANSFER SET (K820447) | Alpha Therapeutic Corp. | 1982-04-14 |
| LECTIN-A (K820368) | American Dade | 1982-04-14 |
| SICKLE-CHECK (K820642) | Panmed, Inc. | 1982-04-14 |
| PLASMA POOLER HEAT SEALER (K820301) | North American Biologicals, Inc. | 1982-04-09 |
| GELMAN GLYCO-PHORE BUFFER (K820518) | Gelman Sciences, Inc. | 1982-04-09 |
| CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY (K813033) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-04-09 |
| GLYCO-GEL TEST KIT (K820279) | Pierce Chemical Co. | 1982-04-08 |
| DISPO FIBRIN PIPET TIPS B4182-2 (K820532) | American Scientific Products | 1982-04-08 |
| HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (K820787) | Helena Laboratories | 1982-04-08 |
| MEM VITAMINS (100X (K820509) | Dutchland Laboratories, Inc. | 1982-04-08 |
| B4182-1 (K820533) | American Scientific Products | 1982-04-08 |
| HELENA HEMOGLOBIN DETECT COLUMN SYS (K820573) | Helena Laboratories | 1982-04-01 |
| SODIUM PYRUVATE (100MM) (K820495) | Dutchland Laboratories, Inc. | 1982-03-26 |
| CYANMETHEMOGLOBIN TEST (K820596) | Boehringer Mannheim Corp. | 1982-03-26 |
| AVES WRIGHT STAIN (K820437) | Helena Laboratories | 1982-03-26 |
| THROMBOSCREEN (K820450) | Pacific Hemostasis | 1982-03-26 |
| MEM NON-ESSENTIAL AMINO ACIDS (100X) (K820508) | Dutchland Laboratories, Inc. | 1982-03-26 |
| TRICHROME STAIN (K820634) | Volu Sol Medical Industries | 1982-03-26 |
| PLATELET AGGREGOMETERS (K820422) | Chrono-Log Corp. | 1982-03-16 |
| ORTHO* HEMATOLOGY CONTROL 8 NORMAL (K820400) | Ortho Diagnostic Systems, Inc. | 1982-03-15 |
| ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW (K820401) | Orhto Diagnostic Systems, Inc. | 1982-03-15 |
| MONO-POLY RESOLVING MEDIUM (K812947) | Flow Laboratories, Inc. | 1982-03-11 |
| LECTIN H (K813413) | American Dade | 1982-03-04 |
| ROCKING/CIRCULATING CYTO-THERM II 3570 (K813489) | Cryosan, Inc. | 1982-03-04 |
| FE-CULT PLUS (K820072) | Gamma Biologicals, Inc. | 1982-03-04 |
| GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (K813342) | Gamma Biologicals, Inc. | 1982-03-04 |
| DADE FACTOR ASSAY REFERENCE PLASMA (K820085) | American Dade | 1982-02-23 |
| HEMOTOLOGY CALIBRATOR (K813530) | American Dade | 1982-02-22 |
| CLOTTING TIME REAGENT (K820084) | American Dade | 1982-02-22 |
| GLYCO-SEP REAGENT TEST SET (K820076) | Clin Tech Diagnostics Corp. | 1982-02-12 |
| FREEZE DRIED FICIN (K813404) | Biological Corp. of America | 1982-02-10 |
| SICKLE-CHECK (K820037) | Diagnostic Technology, Inc. | 1982-02-04 |
| MODIFIED EA 50 (K820027) | Surgipath | 1982-02-04 |
| HEMATOLOGY CALIBRATOR S-CAL (K813375) | Coulter Electronics, Inc. | 1982-02-04 |
| COAG-A-MATE X2 (K813564) | General Diagnostics | 1982-01-28 |
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