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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
42
Latest Decision
1981-06-18

Clearances · page 38 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K811400 HEMAQUIK Accra Laboratories, Inc. IAF Class I 1981-06-18
K803218 CELL DYN 800 HEMATOLOGY ANALYZER Abbott Diagnostics GKL Class II 1981-06-09
K810976 ALPHA-THAL SCREEN TM CONTROL Isolab, Inc. LGL Class II 1981-05-29
K811011 HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE Sigma Chemical Co. GIA Class I 1981-05-15
K810781 L-GLUTAMINE Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810771 L-15 MEDIUM (MODIFIED) Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810769 MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810774 WATER-TISSUE CULTURE GRADE Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810772 MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810770 MED. 199(MODIFIED) W/HANKS' SALTS Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810780 SODIUM BICARBONATE (7.5%) SOLUTION Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810779 EARLE'S BALANCED SALTS SOULTION Dutchland Laboratories, Inc. KIP Class I 1981-05-13
K810783 ALSEVER'S SOLUTION (MODIFIED) Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810778 BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810782 TRYPAN BLUE (0.5% IN NORMAL SALINE) Dutchland Laboratories, Inc. LGY Class I 1981-05-13
K810776 PENICILLIN-STREPTOMYCIN MIXTURE Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810773 BASAL MEDIUM EAGLE W/HANKS' SALTS Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810768 MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS Dutchland Laboratories, Inc. KIT Class I 1981-05-13
K810766 HANKS' BALANCED SALT SOLUTION W/O CA-MG Dutchland Laboratories, Inc. KIP Class I 1981-05-08
K810488 HOME HEALTH CHEKUP KIT Healthkit KHE Class II 1981-05-08
K810767 RPMI 1640 MEDIUM Dutchland Laboratories, Inc. KIT Class I 1981-05-08
K810775 GOAT SERUM-STERILE Dutchland Laboratories, Inc. KIS Class I 1981-05-08
K811000 ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL Corning Medical & Scientific LCP Class II 1981-05-08
K810711 HAEMONETICS 600 ML. COMPONENT BAG Haemonetics Corp. KSR Class II 1981-05-08
K810714 LANCER GLYCOSYLATED HEMOGLOBIN ASSAY Sherwood Medical Co. LCP Class II 1981-05-08
K810777 HANKS' BALANCED SALTS SOLUTION (MODIF.) Dutchland Laboratories, Inc. KIP Class I 1981-05-08
K810638 LANCER GLYCOSYLATED HEMOGLOBIN Sherwood Medical Co. LCP Class II 1981-05-08
K810899 TECHNICON AUTOGROUPER 16-C SYSTEM Technicon Instruments Corp. KSZ Class II 1981-05-05
K810875 FECAL STAINING KIT Jayco Pharmaceuticals KKJ Class I 1981-05-01
K810874 FETAL CALF SERUM Tissue Culture Biologicals KIS Class I 1981-04-23
K810919 HEMOGLOBIN ELECTROPHORESIS CONTROL Isolab, Inc. JBD Class II 1981-04-23
K810903 NEWBORN BOVINE SERUM Biolabs, Inc. KIS Class I 1981-04-14
K810758 GILL'S HEMATOXYLIN #1 Surgipath HYJ Class I 1981-04-14
K810759 GILL'S HEMATOXYLIN #2 Surgipath HYJ Class I 1981-04-14
K810733 HARRIS HEMATOXYLIN Surgipath HYK Class I 1981-04-14
K810904 BOVINE CALF SERUM Biolabs, Inc. KIS Class I 1981-04-14
K810350 THROMBOPLASTIN Pacific Hemostasis GJS Class II 1981-04-14
K810684 HEMOCOLOR STAIN SET Harleco ICC Class I 1981-04-08
K810478 ANIMAL SERUM PRODUCTS Animal Health Laboratories, Inc. KIS Class I 1981-04-08
K810617 MOBILE MATIC AUTOMATIC DONOR SCALE Lifeline Instruments, Inc. KSQ Class I 1981-04-07
K803128 SERIES 810 PLATELET ANALYZER J.T. Baker Chemical Co. GKL Class II 1981-04-03
K810313 HAEMONETICS 1400 ML THERAPEUTIC BAG Haemonetics Corp. KSR Class II 1981-03-31
K810599 DADE RH CONTROL REAGENT American Dade KSF Class II 1981-03-31
K810475 HELENA HEMOGLOBIN F CONTROLS Helena Laboratories KQI Class II 1981-03-26
K810784 FUNGIZONE Dutchland Laboratories, Inc. KIT Class I 1981-03-23
K810495 STAT STAIN SET Accra Laboratories, Inc. IAF Class I 1981-03-17
K803081 QUANTICHECK CONTROL PLASMA Abbott Laboratories GGQ Class II 1981-03-17
K801054 THROMBO-TEST (X) Medtro GmbH JPK Class II 1981-03-13
K803095 COPPER SULFATE SOLUTION SP. GR.1.055 Accra Laboratories, Inc. KSL Class I 1981-03-06
K810268 NORMLCERA Medical Specialties Laboratories KIS Class I 1981-03-06
K810058 ORTHO QUANTITATIVE FIBRINOGEN ASSAY Ortho Diagnostic Systems, Inc. KQJ Class II 1981-02-26
K803110 PROTEOLYTIC ENZYME CONTROL American Dade LGP Class II 1981-02-17
K802840 ALPHA-ANTIPLASM ASSAY American Dade LGP Class II 1981-02-17
K810040 ACRIDINE ORANGE STAIN Bd Becton Dickinson Vacutainer Systems Preanalytic IDC Class I 1981-02-12
K803304 ACRIDINE ORANGE STAIN Remel Co. IDC Class I 1981-02-12
K810047 AUTOPHOR 128 Gelman Sciences, Inc. JBD Class II 1981-02-05
K802199 STAT-CRIT HEMATOCRIT MEASURING INSTRU United States Surgical, A Division of Tyco Healthc GKF Class II 1981-02-04
K803248 AMES SERA-PAK HEMOGLOBIN REAGENT Miles Laboratories, Inc. KHG Class II 1981-01-26
K803219 ADC-500 AUTOMATED DIFFER. CELL CNTR. SY. Abbott Laboratories GKZ Class II 1981-01-21
K803186 NORMAL AND ELEVATED CONTROL FOR GLYCO. Applied Clinical Research Laboratories LCP Class II 1981-01-21
K801771 ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT Isolab, Inc. LGL Class II 1981-01-16
K802832 SANDARE GLYCOHEMOGLOBIN PROCEDURE Sandare Chemical Co., Inc. LCP Class II 1981-01-16
K802940 SUPER-SPIKE TRANSFER SET Geneva Laboratories, Inc. KSB Class II 1981-01-15
K803108 HELENA HBA2 QUIK COLUMN METHOD Helena Laboratories JPD Class II 1981-01-09
K802690 ULTRAPAK CAT. #100-0251 Occumedics, Inc. HYG Class I 1981-01-08
K803084 ORTHO HEMATOLOGY CONTROL ABNORMAL LOW Ortho Instruments JPK Class II 1980-12-31
K803073 ORTHO HEMATOLOGY CONTROL Ortho Instruments JPK Class II 1980-12-31
K802268 CRC(CYANMETHEMOGLOBIN REAGENT CONCENT R&D Systems, Inc. KHG Class II 1980-12-31
K803083 ORTHO HEMOTOLOGY CONTROL-NORMAL Ortho Instruments JPK Class II 1980-12-31
K803016 HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. Helena Laboratories GKR Class II 1980-12-30
K803041 SERUM FREE TISSUE CULTURE MEDIA Cartaya Assoc. KIT Class I 1980-12-30
K803015 HEMESPEC II Helena Laboratories GKR Class II 1980-12-30
K802912 HELENA AT-III QUIPLATE PROCEDURE Helena Laboratories JBQ Class II 1980-12-22
K802884 CORNING NORMAL GLYCOSYLATED HEMOGLOBIN Corning Medical & Scientific JBD Class II 1980-12-22
K802721 GLYCOHEMOGLOBIN IN WHOLE BLOOD Sigma Chemical Co. LCP Class II 1980-12-11
K802636 PLATELET COUNTING KIT Streck Laboratories, Inc. GKL Class II 1980-12-11
K802821 PARAGON HEMOGLOBIN ELECTRO. REAG. KIT Beckman Instruments, Inc. JBD Class II 1980-12-11
K802742 SERA-PAK TOTAL PROTEIN REAGENT Miles Laboratories, Inc. GGK Class I 1980-12-11
K802608 HEMATIC BLOOD MIXER Helmer Labs, Inc. KSQ Class I 1980-12-11
K802432 GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. Clin Tech Diagnostics Corp. LCP Class II 1980-12-01
K802356 VON WILLEBRAND FACTOR ASSAY Bio/Data Corp. GGP Class II 1980-12-01
K802232 AB-TROL COAGULATION CONTROL Helena Laboratories GGW Class II 1980-11-12
K802569 ABNORMAL HEMOGLOBIN CONTROL Marilyn L. Amick KHG Class II 1980-11-12
K802568 HEMOGLOBIN CONTROL Marilyn L. Amick KHG Class II 1980-11-12
K802265 CBC PLT-4 R&D Systems, Inc. JPK Class II 1980-11-12
K802533 GAMMA LEWIS BLOOD GROUP SUBSTANCE Gamma Biologicals, Inc. KSX Class II 1980-11-12
K802267 PLT-4 SIZE-CHECK R&D Systems, Inc. JPK Class II 1980-11-12
K802534 GAMMA PI BLOOD GROUP SUBSTANCE Gamma Biologicals, Inc. KSX Class II 1980-11-12
K801233 CELLTRIFUGE II Travenol Laboratories, S.A. GKT Class II 1980-10-31
K802418 FETAL BOVINE SERUM S&S Biologicals KIS Class I 1980-10-31
K801082 GAMBRO HEMOFREEZE-BAG Gambro, Inc. KSR Class II 1980-10-31
K801219 PLASMAPOOLER North American Biologicals, Inc. KSR Class II 1980-10-31
K802266 HGB3 (1:251) R&D Systems, Inc. GKR Class II 1980-10-23
K802141 CH-60 PLUS WHOLE BLOOD PLATELET CONTROL American Dade JPK Class II 1980-10-10
K801841 FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) American Hospital Supply Corp. GHH Class II 1980-10-10
K802233 GLYCOSYLATED HEMOGLOBIN-SMC COLUMN Helena Laboratories LCP Class II 1980-10-10
K802094 ORTHO SPECTRUM Ortho Instruments GKL Class II 1980-10-10
K802319 HEMOTEMP TM Marion Laboratories, Inc. KSE Class II 1980-10-10
K802142 CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL American Dade JPK Class II 1980-10-10
K802143 CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET American Dade JPK Class II 1980-10-10

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