Atlas FDA

Hematology

4,194 FDA 510(k) clearances · Medical specialty

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (K811011)Sigma Chemical Co.1981-05-15
BASAL MEDIUM EAGLE W/HANKS' SALTS (K810773)Dutchland Laboratories, Inc.1981-05-13
ALSEVER'S SOLUTION (MODIFIED) (K810783)Dutchland Laboratories, Inc.1981-05-13
MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE (K810769)Dutchland Laboratories, Inc.1981-05-13
EARLE'S BALANCED SALTS SOULTION (K810779)Dutchland Laboratories, Inc.1981-05-13
L-GLUTAMINE (K810781)Dutchland Laboratories, Inc.1981-05-13
WATER-TISSUE CULTURE GRADE (K810774)Dutchland Laboratories, Inc.1981-05-13
BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT (K810778)Dutchland Laboratories, Inc.1981-05-13
MED. 199(MODIFIED) W/HANKS' SALTS (K810770)Dutchland Laboratories, Inc.1981-05-13
MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS (K810768)Dutchland Laboratories, Inc.1981-05-13
PENICILLIN-STREPTOMYCIN MIXTURE (K810776)Dutchland Laboratories, Inc.1981-05-13
TRYPAN BLUE (0.5% IN NORMAL SALINE) (K810782)Dutchland Laboratories, Inc.1981-05-13
MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE (K810772)Dutchland Laboratories, Inc.1981-05-13
L-15 MEDIUM (MODIFIED) (K810771)Dutchland Laboratories, Inc.1981-05-13
SODIUM BICARBONATE (7.5%) SOLUTION (K810780)Dutchland Laboratories, Inc.1981-05-13
RPMI 1640 MEDIUM (K810767)Dutchland Laboratories, Inc.1981-05-08
HOME HEALTH CHEKUP KIT (K810488)Healthkit1981-05-08
HANKS' BALANCED SALTS SOLUTION (MODIF.) (K810777)Dutchland Laboratories, Inc.1981-05-08
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL (K811000)Corning Medical & Scientific1981-05-08
HAEMONETICS 600 ML. COMPONENT BAG (K810711)Haemonetics Corp.1981-05-08
LANCER GLYCOSYLATED HEMOGLOBIN (K810638)Sherwood Medical Co.1981-05-08
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY (K810714)Sherwood Medical Co.1981-05-08
GOAT SERUM-STERILE (K810775)Dutchland Laboratories, Inc.1981-05-08
HANKS' BALANCED SALT SOLUTION W/O CA-MG (K810766)Dutchland Laboratories, Inc.1981-05-08
TECHNICON AUTOGROUPER 16-C SYSTEM (K810899)Technicon Instruments Corp.1981-05-05
FECAL STAINING KIT (K810875)Jayco Pharmaceuticals1981-05-01
HEMOGLOBIN ELECTROPHORESIS CONTROL (K810919)Isolab, Inc.1981-04-23
FETAL CALF SERUM (K810874)Tissue Culture Biologicals1981-04-23
NEWBORN BOVINE SERUM (K810903)Biolabs, Inc.1981-04-14
GILL'S HEMATOXYLIN #1 (K810758)Surgipath1981-04-14
HARRIS HEMATOXYLIN (K810733)Surgipath1981-04-14
THROMBOPLASTIN (K810350)Pacific Hemostasis1981-04-14
GILL'S HEMATOXYLIN #2 (K810759)Surgipath1981-04-14
BOVINE CALF SERUM (K810904)Biolabs, Inc.1981-04-14
ANIMAL SERUM PRODUCTS (K810478)Animal Health Laboratories, Inc.1981-04-08
HEMOCOLOR STAIN SET (K810684)Harleco1981-04-08
MOBILE MATIC AUTOMATIC DONOR SCALE (K810617)Lifeline Instruments, Inc.1981-04-07
SERIES 810 PLATELET ANALYZER (K803128)J.T. Baker Chemical Co.1981-04-03
HAEMONETICS 1400 ML THERAPEUTIC BAG (K810313)Haemonetics Corp.1981-03-31
DADE RH CONTROL REAGENT (K810599)American Dade1981-03-31
HELENA HEMOGLOBIN F CONTROLS (K810475)Helena Laboratories1981-03-26
FUNGIZONE (K810784)Dutchland Laboratories, Inc.1981-03-23
STAT STAIN SET (K810495)Accra Laboratories, Inc.1981-03-17
QUANTICHECK CONTROL PLASMA (K803081)Abbott Laboratories1981-03-17
THROMBO-TEST (X) (K801054)Medtro GmbH1981-03-13
NORMLCERA (K810268)Medical Specialties Laboratories1981-03-06
COPPER SULFATE SOLUTION SP. GR.1.055 (K803095)Accra Laboratories, Inc.1981-03-06
ORTHO QUANTITATIVE FIBRINOGEN ASSAY (K810058)Ortho Diagnostic Systems, Inc.1981-02-26
ALPHA-ANTIPLASM ASSAY (K802840)American Dade1981-02-17
PROTEOLYTIC ENZYME CONTROL (K803110)American Dade1981-02-17
ACRIDINE ORANGE STAIN (K810040)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-02-12
ACRIDINE ORANGE STAIN (K803304)Remel Co.1981-02-12
AUTOPHOR 128 (K810047)Gelman Sciences, Inc.1981-02-05
STAT-CRIT HEMATOCRIT MEASURING INSTRU (K802199)United States Surgical, A Division of Tyco Healthc1981-02-04
AMES SERA-PAK HEMOGLOBIN REAGENT (K803248)Miles Laboratories, Inc.1981-01-26
NORMAL AND ELEVATED CONTROL FOR GLYCO. (K803186)Applied Clinical Research Laboratories1981-01-21
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY. (K803219)Abbott Laboratories1981-01-21
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT (K801771)Isolab, Inc.1981-01-16
SANDARE GLYCOHEMOGLOBIN PROCEDURE (K802832)Sandare Chemical Co., Inc.1981-01-16
SUPER-SPIKE TRANSFER SET (K802940)Geneva Laboratories, Inc.1981-01-15
HELENA HBA2 QUIK COLUMN METHOD (K803108)Helena Laboratories1981-01-09
ULTRAPAK CAT. #100-0251 (K802690)Occumedics, Inc.1981-01-08
ORTHO HEMOTOLOGY CONTROL-NORMAL (K803083)Ortho Instruments1980-12-31
ORTHO HEMATOLOGY CONTROL (K803073)Ortho Instruments1980-12-31
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW (K803084)Ortho Instruments1980-12-31
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT (K802268)R&D Systems, Inc.1980-12-31
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. (K803016)Helena Laboratories1980-12-30
HEMESPEC II (K803015)Helena Laboratories1980-12-30
SERUM FREE TISSUE CULTURE MEDIA (K803041)Cartaya Assoc.1980-12-30
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN (K802884)Corning Medical & Scientific1980-12-22
HELENA AT-III QUIPLATE PROCEDURE (K802912)Helena Laboratories1980-12-22
HEMATIC BLOOD MIXER (K802608)Helmer Labs, Inc.1980-12-11
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT (K802821)Beckman Instruments, Inc.1980-12-11
PLATELET COUNTING KIT (K802636)Streck Laboratories, Inc.1980-12-11
SERA-PAK TOTAL PROTEIN REAGENT (K802742)Miles Laboratories, Inc.1980-12-11
GLYCOHEMOGLOBIN IN WHOLE BLOOD (K802721)Sigma Chemical Co.1980-12-11
VON WILLEBRAND FACTOR ASSAY (K802356)Bio/Data Corp.1980-12-01
GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. (K802432)Clin Tech Diagnostics Corp.1980-12-01
ABNORMAL HEMOGLOBIN CONTROL (K802569)Marilyn L. Amick1980-11-12
GAMMA LEWIS BLOOD GROUP SUBSTANCE (K802533)Gamma Biologicals, Inc.1980-11-12
HEMOGLOBIN CONTROL (K802568)Marilyn L. Amick1980-11-12
AB-TROL COAGULATION CONTROL (K802232)Helena Laboratories1980-11-12
CBC PLT-4 (K802265)R&D Systems, Inc.1980-11-12
GAMMA PI BLOOD GROUP SUBSTANCE (K802534)Gamma Biologicals, Inc.1980-11-12
PLT-4 SIZE-CHECK (K802267)R&D Systems, Inc.1980-11-12
FETAL BOVINE SERUM (K802418)S&S Biologicals1980-10-31
GAMBRO HEMOFREEZE-BAG (K801082)Gambro, Inc.1980-10-31
CELLTRIFUGE II (K801233)Travenol Laboratories, S.A.1980-10-31
PLASMAPOOLER (K801219)North American Biologicals, Inc.1980-10-31
HGB3 (1:251) (K802266)R&D Systems, Inc.1980-10-23
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) (K801841)American Hospital Supply Corp.1980-10-10
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN (K802233)Helena Laboratories1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL (K802141)American Dade1980-10-10
HEMOTEMP TM (K802319)Marion Laboratories, Inc.1980-10-10
ORTHO SPECTRUM (K802094)Ortho Instruments1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL (K802142)American Dade1980-10-10
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET (K802143)American Dade1980-10-10
AUTOLET (K801815)Ulster Scientific, Inc.1980-10-10
FIBRI QUIK (K802117)General Diagnostics1980-09-26
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH (K800857)Helena Laboratories1980-09-26
← Previous Next →

Track Hematology automatically

Every clearance here is in the API, with alerts when new ones post.