Atlas FDA

Hematology

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

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RecordFirmDate
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY (K904253)Ortho Diagnostic Systems, Inc.1991-05-20
COLLAGEN REAGENT CAT. NO. 5368 (K910706)Helena Laboratories1991-05-20
EPINEPHRINE REAGENT, CAT. NO. 5367 (K910680)Helena Laboratories1991-05-20
HITT BY HEMOCHRON(R) (K910181)International Technidyne Corp.1991-05-10
GENESIS I AUTOMATED CELL COUNTER (K910679)Alicia Diagnostics, Inc.1991-05-07
QBC AUTOREADER (K910834)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-07
FHT (FECAL HEME TEST) (K905782)Aerscher, Inc.1991-05-06
HEPARIN CONTROLS, HIGH AND LOW (K910741)Sigma Diagnostics, Inc.1991-04-29
ABS CADKIT (K910636)Panbio, Inc.1991-04-29
HELENA THROMBOPLASTIN REAGENT WITH DILUENT (K905807)Helena Laboratories1991-04-16
HEMOCARD-AS (K910430)Isolab, Inc.1991-04-15
DANAM DATACELL-18 (K910283)Danam Electronics1991-04-12
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY (K905643)Agen Biomedical , Ltd.1991-04-12
PLATELET AGGREGATION REAGENTS (K910286)Medical Diagnostic Technologies, Inc.1991-03-19
HEMOCARD CONTROL (K910431)Isolab, Inc.1991-03-11
HELENA THROMBOPLASTIN REAGENT, MODIFICATION (K905857)Helena Laboratories1991-02-27
DADE PROTEIN C CLOTTING ASSAY (K903468)Baxter Healthcare Corp1991-02-26
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 (K910105)International Technidyne Corp.1991-02-26
RETIC-CHEX (K905524)Streck Laboratories, Inc.1991-02-20
FIBRINOTEST(TM) - FIBRINOGEN ASSAY (K903874)Haemachem, Inc.1991-02-14
HEMASTIX REAGENT STRIPS (K905396)Heraeus Kulzer, Inc.1991-02-11
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 (K905673)Helena Laboratories1991-02-11
ABBOTT VISION(TM) GLYCATED HB (K904027)Abbott Laboratories1991-02-07
COAG-1 PT-NC TEST CARD (K904325)Cardiovascular Diagnostic Services1991-01-25
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (K903531)Medical Innovations Corp.1991-01-25
LIATEST(R) AT III TEST KIT (K905110)American Bioproducts Co.1991-01-24
FREE PROTEIN S REAGENT CAT. NO. 5363 (K904247)Helena Laboratories1991-01-18
GLYC-AFFIN(TM)-GA (K905513)Isolab, Inc.1991-01-15
THE THERATEST ACA TEST (K905301)Theratest Laboratories, Inc.1991-01-14
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-31
COAGULATION REFERENCE PLASMA, NORMAL (K905203)Medical Diagnostic Technologies, Inc.1990-12-28
NEW COBE SATURATION/HEMATOCRIT MONITOR (K904336)Cobe Laboratories, Inc.1990-12-27
GLYC-AFFIN GP (K904814)Isolab, Inc.1990-12-26
NITRO BLUE TETRAZOLIUM REDUCTION (K904022)Sigma Chemical Co.1990-12-18
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION (K904454)International Technidyne Corp.1990-12-17
ANTI-HUMAN LEU-2A (CD8) PE (K904390)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-17
LUPO-TEST REAGENT (K903037)Gradipore , Ltd.1990-12-17
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT (K903995)Sigma Chemical Co.1990-12-13
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE (K904209)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-11
HEMOCHRON(R) HEPARIN RESPONSE TEST (K904003)Intensive Technology, Inc.1990-11-29
ST-4 COAGULATION INSTRUMENT (K904297)American Bioproducts Co.1990-11-13
ELVI 828 DIGICLOT MULTISCAN (K902614)Logos Scientific, Inc.1990-11-08
APTT REAGENT (K904341)Sigma Chemical Co.1990-11-08
MONOHAEM (FECAL OCCULT BLOOD TEST) (K901064)Silenus Laboratories Proprietary , Ltd.1990-11-05
QBC SYSTEM MCHC (K904675)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-11-02
THROMBELASTOGRAPH (K904204)Haemoscope Corp.1990-11-01
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE (K904637)R&D Systems, Inc.1990-10-29
METER TRAX (K904461)Hematronix, Inc.1990-10-26
DSL ERYTHROPOIETIN (DSL # 1100) (K903492)Diagnostic Systems Laboratories, Inc.1990-10-26
CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED (K904464)R&D Systems, Inc.1990-10-23
COAGULATION REFERENCE PLASMA, ABNORMAL (K904073)Medi-Tech, Inc.1990-10-22
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA (K903841)Organon Teknika Corp.1990-10-22
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY (K903665)Unipath , Ltd.1990-10-04
COACUTE ANTITHROMBIN CHROMOGENIC ASSAY (K902393)Kabi Diagnostica1990-09-25
BARTELS EXTRACELLULAR MATRIX (K902726)Baxter Healthcare Corp1990-09-24
STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES (K903698)Statspin Technologies1990-09-17
OPTIMATE HEMOGLOBIN A1C (K896830)Heraeus Kulzer, Inc.1990-09-11
CELL-DYN CALIBRATOR (K902892)Unipath , Ltd.1990-09-10
CELL-DYN 3000 CONTROL (K902391)Unipath , Ltd.1990-08-22
TRI-COUNT 16 (K902389)Hematronix, Inc.1990-08-22
LYMPHO SEP(TM) (K902445)Icn Biomedicals, Inc.1990-08-22
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) (K902639)Incstar Corp.1990-08-22
GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (K902311)Applied Imaging Corp.1990-08-20
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT (K902236)Biosearch Medical Products, Inc.1990-08-14
ACS ONE-STAGE PROTHROMBIN TIME REAGENT (K902468)Analytical Control Systems, Inc.1990-08-10
BIOPOOL PROTEIN C EID KIT AND BULK PLATES (K902566)Biopool AB1990-08-09
SPECTROLYSE ATIII KIT (K902530)Biopool AB1990-08-09
BIOCLOT C KIT (K902528)Biopool AB1990-08-09
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K902556)Analytical Control Systems, Inc.1990-08-06
BECKMAN ANTITHROMBIN III REAGENT KIT (K901977)Beckman Instruments, Inc.1990-08-06
ACS 0.02 M CALCIUM CHLORIDE (K902458)Analytical Control Systems, Inc.1990-08-01
MODIFIED COAG-1 PT TEST CARD (K903019)Cardiovascular Diagnostic Services1990-08-01
HEMA-SCREEN (K902360)Immunostics Co., Inc.1990-07-27
COAGULATION CONTROL, LEVEL III (K902363)Sigma Chemical Co.1990-07-26
COAGULATION CONTROL, LEVEL II (K902362)Sigma Chemical Co.1990-07-26
COAGULATION CONTROL, LEVEL I (K902361)Sigma Chemical Co.1990-07-26
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) (K902455)Analytical Control Systems, Inc.1990-07-24
ABNORMAL GLYCOHEMOGLOBIN CONTROL (K902457)Analytical Control Systems, Inc.1990-07-24
OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION (K902263)Trimedyne, Inc.1990-07-23
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY (K901874)Kabi Diagnostica1990-07-20
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL (K902081)Hemotec, Inc.1990-07-03
THROMBOPLASTIN WITH CALCIUM (K902096)Sigma Chemical Co.1990-07-03
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA (K902210)Ortho Diagnostic Systems, Inc.1990-07-03
DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) (K896582)Primus, Inc.1990-06-28
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (K902028)Norfolk Scientific, Inc.1990-06-20
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE (K902083)Helena Laboratories1990-06-15
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 (K901414)Helena Laboratories1990-06-15
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY (K900718)Roche Diagnostic Systems, Inc.1990-06-12
PARA 12 PLUS (K901875)Streck Laboratories, Inc.1990-05-30
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 (K901380)Helena Laboratories1990-05-25
ORTHO CORRECTION REAGENTS (K901327)Ortho Diagnostic Systems, Inc.1990-05-25
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K901143)Helena Laboratories1990-05-23
KOAGULAB 60-S COAGULATION SYSTEM (K901120)Ortho Diagnostic Systems, Inc.1990-05-22
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) (K900939)Incstar Corp.1990-05-16
ANTI-HUMAN LEU-3A (CD4) FITC (K900802)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-05-15
THROMBOPLASTIN.C PLUS (K901325)Baxter Healthcare Corp1990-05-02
COAG-A-MATE - RA4 (K900917)Organon Teknika Corp.1990-04-16
RDW AND MPV INDICES ON HEMAT 12 (K900684)Texas Intl. Laboratories, Inc.1990-04-16
CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (K900685)Texas Intl. Laboratories, Inc.1990-04-16
COAG-A-MATE - RA4 (K900895)Organon Teknika Corp.1990-04-16
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