Hematology
4,194 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| SERACULT OCCULT BLOOF TEST (K813204) | Propper Mfg. Co., Inc. | 1982-01-28 |
| HEPAQUANT (K813011) | Streck Laboratories, Inc. | 1982-01-26 |
| CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (K813395) | Helena Laboratories | 1981-12-31 |
| SEPCOR TEMPERATURE MONITOR (K813327) | Separation Science Corp. | 1981-12-31 |
| COATEST ANTITHROMBIN (K812829) | Kabivitrum, Inc. | 1981-12-30 |
| GRAM STAIN REAGENTS AND KIT (K813369) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-22 |
| FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN (K812298) | Syn-Kit, Inc. | 1981-12-17 |
| UROPAPER EIKEG (K811815) | Syn-Kit, Inc. | 1981-12-10 |
| DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM (K812885) | Dutchland Laboratories, Inc. | 1981-11-24 |
| ACA ANTITHROMBIN III PLASMINOGEN CALIB (K812626) | E.I. Dupont DE Nemours & Co., Inc. | 1981-11-24 |
| ACA FIBRINOGEN CALIBRATOR (K812628) | E.I. Dupont DE Nemours & Co., Inc. | 1981-11-24 |
| TANARAMA (K812603) | Marketing Consultants of America | 1981-11-20 |
| LANCER COAGENT HUMAN VACTOR VIII PLASMA (K812975) | Sherwood Medical Co. | 1981-11-16 |
| LANCER COAGENT HUMAN FACTOR 1X PLASMA (K812974) | Sherwood Medical Co. | 1981-11-16 |
| DIGICLOT 2-#820 (K812121) | Volu Sol Medical Industries | 1981-11-16 |
| MULTI CLOT-#819 (K812122) | Volu Sol Medical Industries | 1981-11-10 |
| CHANG MEDIUM (K812820) | Hana Biologics, Inc. | 1981-11-10 |
| IMMUNO-CELL IMMUNO-SEP KIT (K812411) | Kallestad Laboratories, Inc. | 1981-11-10 |
| S/P CAPILLARY TUBES, HEPARINIZED (2A) (K812969) | American Dade | 1981-11-06 |
| S/P SURE-CAP (K812921) | American Dade | 1981-11-06 |
| S/P SURE-CAP N (K812923) | American Dade | 1981-11-06 |
| S/P CAPILLARY TUBES, HEPARINIZED (3A) (K812970) | American Dade | 1981-11-06 |
| S/P SURE-CAP C (K812922) | American Dade | 1981-11-06 |
| FE-CULT PLUS (K811752) | Gamma Biologicals, Inc. | 1981-11-02 |
| ELUAID (K812002) | Ortho Diagnostic Systems, Inc. | 1981-10-28 |
| S/P SERUM DROPPER PIPETS (K812892) | American Dade | 1981-10-27 |
| ACCRA LAB HEMOTOLOGY (K812848) | Accra Laboratories, Inc. | 1981-10-23 |
| HELENA COLOSCREEN METHOD (K812428) | Helena Laboratories | 1981-10-23 |
| ELUTION SOLUTION (K812565) | Biological Corp. of America | 1981-10-23 |
| AVI-D CONTROL (K811713) | Ortho Diagnostic Systems, Inc. | 1981-10-23 |
| CELL CULTURE REAGENTS (K812531) | M.A. Bioproducts | 1981-10-23 |
| ACA ANTITHROMBIN III TEST PACK (K812627) | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-08 |
| ACA FIBRINOGEN TEST PACK (K812629) | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-08 |
| CI-TROL HEPARIN CONTROLS, LOW/HIGH (K812424) | American Dade | 1981-10-02 |
| MLA ELECTRA 700 (K812124) | Medical Laboratory Automation Systems, Inc. | 1981-10-02 |
| LABCER FIBRINOGEN ASSAY KIT & CALIBR. (K812570) | Sherwood Medical Co. | 1981-10-02 |
| VITROGEN TM 100 (K812617) | Collagen Corp. | 1981-10-02 |
| PLATELET AGITATOR (K812533) | Helmer Labs, Inc. | 1981-09-29 |
| AFB STAIN SET (K812668) | Carr-Scarborough Microbiologicals, Inc. | 1981-09-29 |
| CELL-CHEX RBC (K811741) | Streck Laboratories, Inc. | 1981-09-24 |
| LOW FIBRINOGEN CONTROL (K812108) | Bio/Data Corp. | 1981-09-24 |
| ALPHA PLASTIC PLASMA BOTTLE (K810897) | Alpha Therapeutic Corp. | 1981-09-23 |
| BLOOD FREEZING BAG (K810500) | Delmed, Inc. | 1981-09-23 |
| ACCRA LAB WRIGHT STAIN (K812504) | Accra Laboratories, Inc. | 1981-09-23 |
| EM-X (K812222) | Biological Corp. of America | 1981-09-23 |
| FACTOR VIII DEFICIENT PLASMA #B8D (K812431) | Sigma Chemical Co. | 1981-09-23 |
| ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S (K811567) | Ortho Diagnostic Systems, Inc. | 1981-09-16 |
| CIRCULATING CYTO-THERMS (K812311) | Cryosan, Inc. | 1981-09-16 |
| GLYCOHEMOGLOBIN (K810958) | Macomb Chemical Co. | 1981-09-16 |
| CRYOSAN NORMAL SALINE (K812309) | Cryosan, Inc. | 1981-09-16 |
| HEMOTOLOGY QUALITY CONTROL MIXTURE (K812237) | American Dade | 1981-09-09 |
| HEMATOLOGY CONTROL (K812280) | American Dade | 1981-09-09 |
| PLASMA FLEX (K811523) | Terumo America, Inc. | 1981-09-09 |
| CORDISNHYPERION HEMOGLOBIN A1 TEST SYS (K812242) | Cordis Corp. | 1981-09-09 |
| NEWBORN CALF SERUM - STERILE (K812384) | Dutchland Laboratories, Inc. | 1981-09-08 |
| NATAL CALF (BOVINE) SERUM - STERILE (K812385) | Dutchland Laboratories, Inc. | 1981-09-08 |
| DONOR HORSE SERUM - STERILE (K812381) | Dutchland Laboratories, Inc. | 1981-09-08 |
| CALF (BOVINE) SERUM - STERILE (K812383) | Dutchland Laboratories, Inc. | 1981-09-08 |
| FETAL BOVINE SERUM - STERILE (K812386) | Dutchland Laboratories, Inc. | 1981-09-08 |
| RABBIT SERUM - STERILE (K812380) | Dutchland Laboratories, Inc. | 1981-09-08 |
| GUINEA PIG SERUM - STERILE (K812379) | Dutchland Laboratories, Inc. | 1981-09-08 |
| DONOR CALF (BOVINE-SERUM) - STERILE (K812382) | Dutchland Laboratories, Inc. | 1981-09-08 |
| ACRIDINE ORANGE STAIN (K812212) | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
| HELENA HBF QUIPLATE CONTROL (K812226) | Helena Laboratories | 1981-09-01 |
| ZETA-SERA D (K812329) | Amf Biological and Diagnostics Co. | 1981-09-01 |
| AURAMINE O MYCROBACTERIAL STAIN SET (K812274) | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
| VENTREX DATA REDUCTION & QUAL. CONTR. SY (K812357) | Ventrex Laboratories, Inc. | 1981-09-01 |
| ANTITHROMBIN III SCREEN KIT (K812215) | Pacific Hemostasis | 1981-09-01 |
| LACTO-PHENOL ANILINE BLUE MOUNTING FLUID (K812192) | American Scientific Products | 1981-08-31 |
| KING DIAGNOSTICS HEMOGLOBIN TEST (K812127) | King Diagnostics, Inc. | 1981-08-25 |
| HEMASPINNER (K811534) | Geometric Data, Div. Smithkline Corp. | 1981-08-18 |
| HELENA SICKLE-THAL QUIK COLUMN METHOD (K812077) | Helena Laboratories | 1981-08-18 |
| EA 65 (K812086) | Surgipath | 1981-08-13 |
| EA 50 (K812087) | Surgipath | 1981-08-13 |
| TECHNICON H6000 (90/HR) HEMATOLOGY SYS (K811978) | Technicon Instruments Corp. | 1981-08-12 |
| LPC II (K812031) | Labtronix Corp. | 1981-08-12 |
| SICKLE CELL REAGENT SET (K811828) | Anco Medical Reagents & Assoc. | 1981-08-12 |
| HEMATOXYLIN (K811802) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| EOSIN-Y (K811797) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| ORTHO SICKLE CELL CONTROLS (K811894) | Ortho Diagnostic Systems, Inc. | 1981-07-27 |
| ARACHIDONIC ACID (K811290) | Bio/Data Corp. | 1981-07-27 |
| SIGMA PROCEDURE #890 (K811784) | Sigma Chemical Co. | 1981-07-27 |
| ACCRA-LAB GRAM STAIN SET 55760 (K811780) | Accra Laboratories, Inc. | 1981-07-27 |
| CHEMSTRIP L (K811189) | Biodynamics Corp. | 1981-07-27 |
| PLA-MATE (K803071) | Labex, Inc. | 1981-07-24 |
| LABTRONIX PLATELET COUNTER(L/O/C.) (K811084) | Labtronix Corp. | 1981-07-23 |
| FREEZE DRIED PAPAIN (K810803) | Biological Corp. of America | 1981-07-21 |
| ACTIN FS ACTIVATED PTT REAGENT (K811589) | American Dade | 1981-07-16 |
| THROMBIN CLOTTING TIME (K811109) | Bio/Data Corp. | 1981-07-16 |
| BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST (K811710) | Bio-Rad | 1981-07-15 |
| PARA-PAK (K811722) | Meridian Diagnostics, Inc. | 1981-07-15 |
| FIBRINOGEN CONTROL PLASMA (K811069) | American Dade | 1981-07-10 |
| EOSIN Y (K811826) | Surgipath | 1981-07-10 |
| ORANGE G-6 (K811825) | Surgipath | 1981-07-10 |
| HAEMONETICS 1000ML COMPONENT BAG (K811449) | Haemonetics Corp. | 1981-07-01 |
| LASER-CAL (K811063) | Diagnostic Technology, Inc. | 1981-07-01 |
| HEMOTOLOGY QUALITY CONTROL MIXTURES (K810756) | Scientific Standards, Inc. | 1981-06-30 |
| HEMAQUIK (K811400) | Accra Laboratories, Inc. | 1981-06-18 |
| CELL DYN 800 HEMATOLOGY ANALYZER (K803218) | Abbott Diagnostics | 1981-06-09 |
| ALPHA-THAL SCREEN TM CONTROL (K810976) | Isolab, Inc. | 1981-05-29 |
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