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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
54
Latest Decision
1982-02-04

Clearances · page 37 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813375 HEMATOLOGY CALIBRATOR S-CAL Coulter Electronics, Inc. KSA Class II 1982-02-04
K820037 SICKLE-CHECK Diagnostic Technology, Inc. JCM Class II 1982-02-04
K813564 COAG-A-MATE X2 General Diagnostics GKP Class II 1982-01-28
K813204 SERACULT OCCULT BLOOF TEST Propper Mfg. Co., Inc. KHE Class II 1982-01-28
K813011 HEPAQUANT Streck Laboratories, Inc. JOX Class II 1982-01-26
K813395 CELLULOSE ACETATE-CITRATE AGAR HEMOGLO Helena Laboratories JBD Class II 1981-12-31
K813327 SEPCOR TEMPERATURE MONITOR Separation Science Corp. KSE Class II 1981-12-31
K812829 COATEST ANTITHROMBIN Kabivitrum, Inc. JBQ Class II 1981-12-30
K813369 GRAM STAIN REAGENTS AND KIT Bd Becton Dickinson Vacutainer Systems Preanalytic JTS Class I 1981-12-22
K812298 FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN Syn-Kit, Inc. GHH Class II 1981-12-17
K811815 UROPAPER EIKEG Syn-Kit, Inc. KHE Class II 1981-12-10
K812885 DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM Dutchland Laboratories, Inc. KIT Class I 1981-11-24
K812626 ACA ANTITHROMBIN III PLASMINOGEN CALIB E.I. Dupont DE Nemours & Co., Inc. JBQ Class II 1981-11-24
K812628 ACA FIBRINOGEN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. GFX Class II 1981-11-24
K812603 TANARAMA Marketing Consultants of America GGG Class II 1981-11-20
K812121 DIGICLOT 2-#820 Volu Sol Medical Industries JPA Class II 1981-11-16
K812974 LANCER COAGENT HUMAN FACTOR 1X PLASMA Sherwood Medical Co. GGP Class II 1981-11-16
K812975 LANCER COAGENT HUMAN VACTOR VIII PLASMA Sherwood Medical Co. GGP Class II 1981-11-16
K812122 MULTI CLOT-#819 Volu Sol Medical Industries JPA Class II 1981-11-10
K812820 CHANG MEDIUM Hana Biologics, Inc. KIT Class I 1981-11-10
K812411 IMMUNO-CELL IMMUNO-SEP KIT Kallestad Laboratories, Inc. JCF Class I 1981-11-10
K812922 S/P SURE-CAP C American Dade GIO Class I 1981-11-06
K812969 S/P CAPILLARY TUBES, HEPARINIZED (2A) American Dade GIO Class I 1981-11-06
K812970 S/P CAPILLARY TUBES, HEPARINIZED (3A) American Dade GIO Class I 1981-11-06
K812923 S/P SURE-CAP N American Dade GIO Class I 1981-11-06
K812921 S/P SURE-CAP American Dade GIO Class I 1981-11-06
K811752 FE-CULT PLUS Gamma Biologicals, Inc. KHE Class II 1981-11-02
K812002 ELUAID Ortho Diagnostic Systems, Inc. GGK Class I 1981-10-28
K812892 S/P SERUM DROPPER PIPETS American Dade KSS Class I 1981-10-27
K812531 CELL CULTURE REAGENTS M.A. Bioproducts KIT Class I 1981-10-23
K812428 HELENA COLOSCREEN METHOD Helena Laboratories KHE Class II 1981-10-23
K811713 AVI-D CONTROL Ortho Diagnostic Systems, Inc. KSF Class II 1981-10-23
K812848 ACCRA LAB HEMOTOLOGY Accra Laboratories, Inc. IAF Class I 1981-10-23
K812565 ELUTION SOLUTION Biological Corp. of America KSG Class II 1981-10-23
K812629 ACA FIBRINOGEN TEST PACK E.I. Dupont DE Nemours & Co., Inc. KQJ Class II 1981-10-08
K812627 ACA ANTITHROMBIN III TEST PACK E.I. Dupont DE Nemours & Co., Inc. JBQ Class II 1981-10-08
K812617 VITROGEN TM 100 Collagen Corp. KIT Class I 1981-10-02
K812124 MLA ELECTRA 700 Medical Laboratory Automation Systems, Inc. JPA Class II 1981-10-02
K812424 CI-TROL HEPARIN CONTROLS, LOW/HIGH American Dade KFF Class II 1981-10-02
K812570 LABCER FIBRINOGEN ASSAY KIT & CALIBR. Sherwood Medical Co. KQJ Class II 1981-10-02
K812668 AFB STAIN SET Carr-Scarborough Microbiologicals, Inc. JTS Class I 1981-09-29
K812533 PLATELET AGITATOR Helmer Labs, Inc. KSQ Class I 1981-09-29
K811741 CELL-CHEX RBC Streck Laboratories, Inc. KRX Class II 1981-09-24
K812108 LOW FIBRINOGEN CONTROL Bio/Data Corp. KQJ Class II 1981-09-24
K810897 ALPHA PLASTIC PLASMA BOTTLE Alpha Therapeutic Corp. KSR Class II 1981-09-23
K812222 EM-X Biological Corp. of America KSG Class II 1981-09-23
K812431 FACTOR VIII DEFICIENT PLASMA #B8D Sigma Chemical Co. GGP Class II 1981-09-23
K810500 BLOOD FREEZING BAG Delmed, Inc. KSR Class II 1981-09-23
K812504 ACCRA LAB WRIGHT STAIN Accra Laboratories, Inc. IAF Class I 1981-09-23
K810958 GLYCOHEMOGLOBIN Macomb Chemical Co. LCP Class II 1981-09-16
K812311 CIRCULATING CYTO-THERMS Cryosan, Inc. KZL Class II 1981-09-16
K811567 ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S Ortho Diagnostic Systems, Inc. LCP Class II 1981-09-16
K812309 CRYOSAN NORMAL SALINE Cryosan, Inc. GIF Class I 1981-09-16
K812237 HEMOTOLOGY QUALITY CONTROL MIXTURE American Dade JPK Class II 1981-09-09
K812280 HEMATOLOGY CONTROL American Dade JPK Class II 1981-09-09
K811523 PLASMA FLEX Terumo America, Inc. KSR Class II 1981-09-09
K812242 CORDISNHYPERION HEMOGLOBIN A1 TEST SYS Cordis Corp. LCP Class II 1981-09-09
K812379 GUINEA PIG SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812381 DONOR HORSE SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812384 NEWBORN CALF SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812385 NATAL CALF (BOVINE) SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812380 RABBIT SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812386 FETAL BOVINE SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812382 DONOR CALF (BOVINE-SERUM) - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812383 CALF (BOVINE) SERUM - STERILE Dutchland Laboratories, Inc. KIS Class I 1981-09-08
K812357 VENTREX DATA REDUCTION & QUAL. CONTR. SY Ventrex Laboratories, Inc. JPK Class II 1981-09-01
K812212 ACRIDINE ORANGE STAIN Carr-Scarborough Microbiologicals, Inc. IDC Class I 1981-09-01
K812226 HELENA HBF QUIPLATE CONTROL Helena Laboratories KQI Class II 1981-09-01
K812329 ZETA-SERA D Amf Biological and Diagnostics Co. KIS Class I 1981-09-01
K812215 ANTITHROMBIN III SCREEN KIT Pacific Hemostasis JBQ Class II 1981-09-01
K812274 AURAMINE O MYCROBACTERIAL STAIN SET Carr-Scarborough Microbiologicals, Inc. KJK Class I 1981-09-01
K812192 LACTO-PHENOL ANILINE BLUE MOUNTING FLUID American Scientific Products LED Class I 1981-08-31
K812127 KING DIAGNOSTICS HEMOGLOBIN TEST King Diagnostics, Inc. GKR Class II 1981-08-25
K812077 HELENA SICKLE-THAL QUIK COLUMN METHOD Helena Laboratories JPD Class II 1981-08-18
K811534 HEMASPINNER Geometric Data, Div. Smithkline Corp. GKJ Class I 1981-08-18
K812087 EA 50 Surgipath HZJ Class I 1981-08-13
K812086 EA 65 Surgipath HZJ Class I 1981-08-13
K811828 SICKLE CELL REAGENT SET Anco Medical Reagents & Assoc. GHM Class II 1981-08-12
K811978 TECHNICON H6000 (90/HR) HEMATOLOGY SYS Technicon Instruments Corp. GKL Class II 1981-08-12
K812031 LPC II Labtronix Corp. GKL Class II 1981-08-12
K811802 HEMATOXYLIN Richard-Allan Medical Ind., Inc. HYJ Class I 1981-07-28
K811797 EOSIN-Y Richard-Allan Medical Ind., Inc. HYB Class I 1981-07-28
K811894 ORTHO SICKLE CELL CONTROLS Ortho Diagnostic Systems, Inc. GKA Class II 1981-07-27
K811784 SIGMA PROCEDURE #890 Sigma Chemical Co. GJS Class II 1981-07-27
K811290 ARACHIDONIC ACID Bio/Data Corp. JBX Class II 1981-07-27
K811189 CHEMSTRIP L Biodynamics Corp. GHD Class I 1981-07-27
K811780 ACCRA-LAB GRAM STAIN SET 55760 Accra Laboratories, Inc. JTS Class I 1981-07-27
K803071 PLA-MATE Labex, Inc. GKL Class II 1981-07-24
K811084 LABTRONIX PLATELET COUNTER(L/O/C.) Labtronix Corp. GLG Class I 1981-07-23
K810803 FREEZE DRIED PAPAIN Biological Corp. of America KSK Class II 1981-07-21
K811109 THROMBIN CLOTTING TIME Bio/Data Corp. GJA Class II 1981-07-16
K811589 ACTIN FS ACTIVATED PTT REAGENT American Dade GGW Class II 1981-07-16
K811722 PARA-PAK Meridian Diagnostics, Inc. HYI Class I 1981-07-15
K811710 BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST Bio-Rad LCP Class II 1981-07-15
K811826 EOSIN Y Surgipath HYB Class I 1981-07-10
K811069 FIBRINOGEN CONTROL PLASMA American Dade KQJ Class II 1981-07-10
K811825 ORANGE G-6 Surgipath HZH Class I 1981-07-10
K811063 LASER-CAL Diagnostic Technology, Inc. KRX Class II 1981-07-01
K811449 HAEMONETICS 1000ML COMPONENT BAG Haemonetics Corp. KSR Class II 1981-07-01
K810756 HEMOTOLOGY QUALITY CONTROL MIXTURES Scientific Standards, Inc. JPK Class II 1981-06-30

4,197 clearances in the Hematology panel. Data: openFDA.