Atlas FDA

Hematology

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

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RecordFirmDate
LEUKOCYTE VOL. ANALYSIS APPARATUS (K802208)Coulter Electronics, Inc.1980-09-17
ORTHO AUTOMATED CELL COUNTER (K801545)Ortho Instruments1980-09-09
HEP-TROL (K801932)Helena Laboratories1980-09-09
SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA (K801926)Sigma Chemical Co.1980-09-09
MODIFIED BLOOD CELL COUNTING & LYSING (K801357)Coulter Electronics, Inc.1980-08-14
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA (K801346)Nobel Scientific Industries, Inc.1980-08-12
GLYCOSYLATED HEMOGLOBIN KIT (K801561)Amersham Corp.1980-08-12
PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT (K801460)Pacific Hemostasis1980-07-28
VERIFY S PROD. #34141 (K800925)General Diagnostics1980-07-21
HEMOHLOBIN A2 CONTROL-LYOPHILIZED (K801410)Isolab, Inc.1980-07-21
ANTIBODY TO VARICELLA-ZOSTER VIRUS (K800787)Electro-Nucleonics Laboratories, Inc.1980-07-14
PRE-DENT SYSTEM OR PRE-DENT II (K801386)Pre-Dent System1980-07-14
RH CONTROL (K801425)North American Biologicals, Inc.1980-07-14
PRE-DENT SYSTEM MODIFIED (K801516)Pre-Dent System1980-07-14
WHITE BLOOD CELL COUNT CONTROL LEVELS (K801265)Bioscientific1980-07-14
HEMOGLOBIN CONTROL LEVELS (K801268)Bioscientific1980-07-14
RED BLOOD CELL COUNT & HEMATOCRIT CNTL (K801267)Bioscientific1980-07-14
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. (K801422)Sandare Chemical Co., Inc.1980-07-08
LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT (K801289)Leeco Diagnostics, Inc.1980-06-30
TECHNICON H6000 HEMATOLOGY SYSTEM (K801155)Technicon Instruments Corp.1980-06-09
A-GENT QUANTICHROM THROMBIGEN I (K800725)Abbott Laboratories1980-06-04
VOLU-SOL URINARY DICHROME STAIN (K801143)Volu Sol Medical Industries1980-05-30
FIBRINOGEN SCREEN (K800826)Pacific Hemostasis1980-05-30
A-GENT QUANTICHROM THROMBIGEN-E (K800656)Abbott Laboratories1980-05-30
WRIGHTS RAPID STAIN (K801212)Mcb Manufacturing Chemists, Inc.1980-05-30
P1 BLOOD GROUP SUBSTANCE (K800916)Travenol Laboratories, S.A.1980-05-08
FLO TEM (FLUID WARNER) (K800699)Chroma Products, Inc.1980-05-08
VOLU-SOL EOSIN Y STAIN (K800942)Volu Sol Medical Industries1980-05-08
PENTEX BOVINE ALBUMIN 30% SOLUTION (K800943)Miles Laboratories, Inc.1980-05-08
THROMBOQUIK THROMBIN REAGENT PROD. #3551 (K800926)General Diagnostics1980-05-08
TRI-CHECK (K800938)Scientific Standards, Inc.1980-05-08
HEMESPEC CHECK SET (K800852)Helena Laboratories1980-05-02
HELENA COLOCHECK (K800433)Helena Laboratories1980-05-02
FAST HEMOGLOBIN CONTROL-LYOPHILIZED (K800794)Isolab, Inc.1980-04-29
A,SA2 LYOPHILIZED HEMO CONTROL (K800853)Helena Laboratories1980-04-29
A,FDA2 LYOPHILIZED HEMO CONTROL (K800856)Helena Laboratories1980-04-29
A,A2 LYOPHILIZED HEMO CONTROL (K800854)Helena Laboratories1980-04-29
A,FSC LYOPHILIZED HEMO CONTROL (K800855)Helena Laboratories1980-04-29
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS (K800780)Sandare Chemical Co., Inc.1980-04-24
PRE-DENT SYSTEM (K800736)Pre-Dent System1980-04-24
FETAL BOVINE SERUM (K800781)Biolabs, Inc.1980-04-21
MONITEMP BLOOD PACK TEMP. MONITOR (K800667)Liquid Crystal Products, Inc.1980-04-16
RST-SERIES CONTROL (K800658)Gamma Biologicals, Inc.1980-04-16
HEMOSAFE (K800346)Med Lab Systems, Inc.1980-04-16
HEMATO-CHEX (K800361)Streck Laboratories, Inc.1980-04-04
COMPUR M-1000 MINI-PHOTOMETER (K800059)Miles Laboratories, Inc.1980-04-04
ADD OF RETICULOCYTE COUNT/CAPABILITIES (K800533)Abbott Laboratories1980-04-04
HELENA RISTOCETIN (K800432)Helena Laboratories1980-03-25
HEPCON/SYSTEM RC-10 (K800161)Hemotec, Inc.1980-03-19
VARIOUS REAGENTS FOR BLOOD CELL ANALYZER (K800180)Laboratory Products, Inc.1980-03-19
ORTHO ANTISERA CONTROL (K800310)Ortho Diagnostics, Inc.1980-03-05
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (K800296)Dade, Baxter Travenol Diagnostics, Inc.1980-03-05
PHARMAFLEX CRYOGENIC BAG (K792395)Pharmachem Corp.1980-02-26
VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (K800325)Volu Sol Medical Industries1980-02-26
VOLU-SOL EA-50 STAIN (K800322)Volu Sol Medical Industries1980-02-26
VOLU-SOL ORANGE G-6 STAIN (K800323)Volu Sol Medical Industries1980-02-22
VOLU-SOL HARRIS HEMATOXYLIN (K800324)Volu Sol Medical Industries1980-02-22
RH-HR NEGATIVE CONTROL REAGENT (K800239)Gotham Biologics, Inc.1980-02-21
WHOLE BLOOD PLATELET CONTROL NORMAL, (K792606)Dade, Baxter Travenol Diagnostics, Inc.1980-02-13
BOVINE ALBUMIN 22% & 30% SOLUTIONS (K800189)Gotham Biologics, Inc.1980-02-13
ROYCO MODEL 951 CELL MIXER (K800104)Royco Instruments1980-02-06
PLATELET RETENTION (ADHESION) COLUMNS (K800037)Hemometrix1980-02-05
PLATELET AGGREGATION REAGENTS (K800146)Pacific Hemostasis1980-02-05
TECHNICON C/90 SYSTEM (K800121)Technicon Instruments Corp.1980-02-05
COULTER COUNTER MODEL S PLUS (K792537)Coulter Electronics, Inc.1980-01-29
COULTER COUNTER-BLOOD CELL COUNTER (K792668)Coulter Electronics, Inc.1980-01-29
HELENA FACTOR XII DEFICIENT (K792656)Helena Laboratories1980-01-24
HELENA COLOSCREEN (K792655)Helena Laboratories1980-01-24
PARA-PAK(WHEATLEY'S TRICHROME STAIN) (K792706)Meridian Diagnostics, Inc.1980-01-24
PONCEAU S STAIN SET (K792550)Electrophoresis Corp. of America1980-01-16
POLY-LEC SYSTEM (K792582)Gamma Biologicals, Inc.1980-01-16
GAMMA ARACHIS HYPOGEA LECTIN (K792583)Gamma Biologicals, Inc.1980-01-16
THROMBOKINETIC FIBRINOGEN ASSAY (K792563)Bio/Data Corp.1980-01-11
HELENA FACTOR XI DEFICIENT SUBSTRATE (K792476)Helena Laboratories1979-12-31
PLATELET-CHEX FOR BLOOD CENTERS (K792467)Streck Laboratories, Inc.1979-12-31
HELENA FACTOR V DEFICIENT SUBSTRATE (K792507)Helena Laboratories1979-12-31
SANDARE CYANMETHEMOGLOBIN STANDARD (K792358)Sandare Chemical Co., Inc.1979-12-31
SANDARE CYANMETHEMOGLOBIN REAGENT (K792503)Sandare Chemical Co., Inc.1979-12-31
HELENA FACTOR VII DEFICIENT SUB. PLASMA (K792511)Helena Laboratories1979-12-31
HELENA FACTOR IX DEFICIENT SUBSTRATE (K792475)Helena Laboratories1979-12-31
VOLU-SOL NMB RETICULOCYTE STAIN (K792496)Volu Sol Medical Industries1979-12-31
HELENA FACTOR X DEFICIENT SUBSTRATE (K792508)Helena Laboratories1979-12-31
PIASMA SAFE (K792185)Cry-O-Safe, Inc.1979-12-28
HELENA FACTOR II DEFICIENT SUB. PLASMA (K792336)Helena Laboratories1979-12-27
FETAL CHECK (K792546)Alta Diagnostics, Inc.1979-12-18
VOLU-SOL URINARY SEDIMENT STAIN (K792495)Volu Sol Medical Industries1979-12-18
STAINS, COUNTERSTAINS & GEN. PURPOSE (K792483)Laboratory Products, Inc.1979-12-18
FAT RED 7B STAIN SET (K792549)Electrophoresis Corp. of America1979-12-18
VOLU-SOL STATIM STAIN (K792497)Volu Sol Medical Industries1979-12-18
AMIDO BLACK 10B STAIN (K792552)Electrophoresis Corp. of America1979-12-18
SANDARE HEMOGLOBIN CONTROLS (K792209)Sandare Chemical Co., Inc.1979-12-04
NORM-TROL (K792310)Helena Laboratories1979-12-04
HELENA FACTOR VIII DEFICIENT SUB. PLASMA (K792335)Helena Laboratories1979-12-04
RH VIEWBOX (K792306)Tekpro1979-12-04
GLYCO-SPIN (K792086)Applied Clinical Research Laboratories1979-11-30
CORNING GLYCOSYLATED HEMOGLOBIN SET (K791777)Corning Medical & Scientific1979-11-13
WRIGHTS RAPID STAIN (K792026)Mcb Manufacturing Chemists, Inc.1979-11-13
ROYCO MODEL 921 CELL COUNTER (K791867)Royco Instruments1979-11-05
LANCER COAGENT APTT KIT (K792048)Sherwood Medical Co.1979-11-05
PHADECODE XA INHIBITOR ASSAY (K792019)Pharmaseal Div., Baxter Healthcare Corp.1979-11-05
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