Atlas FDA

Hematology

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

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RecordFirmDate
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (K950568)Ortho Diagnostic Systems, Inc.1996-05-13
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (K950625)Ortho Diagnostic Systems, Inc.1996-05-13
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) (K951100)Ortho Diagnostic Systems, Inc.1996-05-13
WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER (K953116)Intl. Remote Imaging Systems1996-05-13
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (K950482)Ortho Diagnostic Systems, Inc.1996-05-10
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM (K935720)Ortho Diagnostic Systems, Inc.1996-05-09
ABBOTT CELL-DYN 3500R SYSTEM (K960427)Sequoia Turner Corp.1996-05-02
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (K954570)Ortho Diagnostic Systems, Inc.1996-04-30
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM (K955355)Bio-Rad1996-04-26
NOVA CO-OXIMETER ANALYZER (K955013)Nova Biomedical Corp.1996-04-25
SYNTHAFAX APTT REAGENT (K955638)Ortho Diagnostic Systems, Inc.1996-04-23
PATHROMTIN SL (K955450)Behring Diagnostics, Inc.1996-04-19
CALIBRATION VERIFICATION ASSESSMENT (CVA) (K960557)Streck Laboratories, Inc.1996-04-03
VENOM TIEM REAGENT (K955115)Medical Diagnostic Technologies, Inc.1996-04-03
MULTI-CENTRIFUGE (K955795)Novonx, Inc.1996-03-29
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE (K955909)Dako Corp.1996-03-28
HEMATIL 18 (H-18) (K953643)Texas Intl. Laboratories, Inc.1996-03-22
TRI-COUNT 20 (K960471)Hematronix, Inc.1996-03-20
BACTIDROP CALCOFLUOR WHITE (K960095)Remel Co.1996-03-19
TRI-COURT 20-T (K960005)Hematronix, Inc.1996-03-19
CALCOFLUOR WHITE STAIN KIT (K960090)Remel Co.1996-03-19
TAS PTONE (K955843)Cardiovascular Diagnostic Services1996-03-18
AMAX CS-190 COAGULATION ANALYZER SYSTEM (K955720)Sigma Diagnostics, Inc.1996-03-13
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (K954006)Intl. Remote Imaging Systems1996-03-12
KC 1A COAGULATION ANALYZER/SET (K955724)Sigma Diagnostics, Inc.1996-03-12
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (K953598)Serono Diagnostics, Inc.1996-03-11
PORCINE FACTOR VIII;C REAGENT (K952321)Helena Laboratories1996-03-11
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM (K955735)Sigma Diagnostics, Inc.1996-03-11
PROTHROMBIN TIME TEST CARD (K954625)Cardiovascular Diagnostics, Inc.1996-03-11
PRIMUS VARIANT SYSTEM PVS99 (K955283)Primus Corp.1996-03-01
BIOCLOT PROTEIN S (K955738)Medical Diagnostic Technologies, Inc.1996-02-29
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II (K952126)Aalto Scientific, Ltd.1996-02-29
CBC-CAL PLUS HEMATOLOGY CALIBRATOR (K955925)R&D Systems, Inc.1996-02-29
FLOW-COUNT COULTER FLUOROSPHERES (K954688)Coulter Corp.1996-02-29
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP (K946055)Becton Dickinson Immunocytometry Systems1996-02-20
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP (K950342)Becton Dickinson Immunocytometry Systems1996-02-20
MULTICHECK (K952725)Radiometer America, Inc.1996-02-20
A549 CELL CULTURE (K955921)Viratest Intl., Inc.1996-02-16
CHROM Z-HEPARIN, CAT. NO 5242 (K952667)Helena Laboratories1996-02-14
CHROM Z-F:VIII, CAT. NO. 5241 (K952668)Helena Laboratories1996-02-09
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P (K952337)Roche Diagnostic Systems, Inc.1996-02-09
COULTER LINEARITY CONTROL (K955334)Coulter Corp.1996-02-08
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898)Genzyme Corp.1996-02-05
QBC ACCUREAD SYSTEM (K955504)Becton Dickinson Diagnostic Instrument Systems1996-02-05
AT-III CONTROL PLASMA KIT (K955040)American Bioproducts Co.1996-01-31
CHROM Z-PROTEIN C, CAT. NO. 5243 (K952666)Helena Laboratories1996-01-30
4C PLUS COULTER CELL CONTROL (K955016)Coulter Corp.1996-01-30
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S (K954437)Haemoscope Corp.1996-01-30
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ (K945212)Dako Corp.1996-01-26
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT (K954997)Centocor, Inc.1996-01-24
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY (K952515)Chromogenix AB1996-01-23
CRYO CHECK LOW FIBRINOGEN CONTROL (K951823)Precision Biologicals, Inc.1996-01-03
CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION (K950916)Caltag Laboratories, Inc.1995-12-21
CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION (K950918)Caltag Laboratories, Inc.1995-12-21
CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K950917)Caltag Laboratories, Inc.1995-12-21
CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION (K951073)Caltag Laboratories, Inc.1995-12-21
CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K950919)Caltag Laboratories, Inc.1995-12-20
IMAGN(TM) 2000 SYSTEM (K945756)Buckman Co., Inc.1995-12-19
CHROM Z-PLASMINOGEN, CAT. NO. 5244 (K952669)Helena Laboratories1995-12-07
SYNTHASIL APTT REAGENT (K953981)Ortho Diagnostic Systems, Inc.1995-11-30
COAGUCHEK SYSTEM (K952625)Boehringer Mannheim Corp.1995-11-21
VARIANT HEMOGLOBINOPATHY PROGRAM (K954048)Bio-Rad1995-11-20
COACUTE HEPARIN (K952514)Chromogenix AB1995-11-20
FACS LOADER SYSTEM (K953302)Becton Dickinson Immunocytometry Systems1995-11-20
MRC-5 CELL CULTURE VIAL (K952727)Viratest Intl., Inc.1995-11-20
ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (K933878)Intracel Corp.1995-11-14
ASSERACHROM TOTAL PROTEIN S KIT (K954040)American Bioproducts Co.1995-11-13
CHROM Z CHROMOGENIC ASSAYS (K951943)Helena Laboratories1995-11-13
ASSERACHROM FREE PROTEIN S KIT (K954017)American Bioproducts Co.1995-11-13
COAMATIC FACTOR VIII (K943225)Pharmacia Hepar, Inc.1995-11-06
CRYO CHECK LUPUS PLASMA (K952623)Precision Biologicals, Inc.1995-11-06
ACL FUTURA COAGULATION SYSTEM (K951891)Instrumentation Laboratory CO1995-11-03
MICROSPIN 24 (K953519)Vulcon Technologies1995-11-03
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (K954188)Immunotech Corp.1995-11-03
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS (K953870)Medtronic Vascular1995-10-31
CRYO CHECK ABNORMAL REFERENCE CHECK I & II (K952624)Precision Biologicals, Inc.1995-10-30
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA (K952622)Precision Biologicals, Inc.1995-10-30
PROTIME MICROCOAGULATION SYSTEM (K951072)International Technidyne Corp.1995-10-27
AGEN DIMERTEST GOLD EIA (K945642)Agen Biomedical , Ltd.1995-10-25
B-FACT, BORDERLINE FACTOR ASSAY CONTROL (K945854)George King Bio-Medical, Inc.1995-10-24
A-FACT, ABNORMAL FACTOR ASSAY CONTROL (K945855)George King Bio-Medical, Inc.1995-10-24
IL682, CO-OXIMETER (K945677)Instrumentation Laboratory CO1995-10-20
OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES (K946335)Immunotech, Inc.1995-10-20
THROMBOPLASTIN-LI REAGENT (K951820)Helena Laboratories1995-10-20
PROTEIN C DEFICIENT PLASMA (K945857)George King Bio-Medical, Inc.1995-10-20
VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (K940003)Buckman Co., Inc.1995-10-19
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (K951496)Abbott Laboratories1995-10-19
ROCHE COBAS MICROS HEMATOLOGY ANALYZER (K953448)Roche Diagnostic Systems, Inc.1995-10-13
MDA SIMPLASTIN LS (K952608)Organon Teknika Corp.1995-10-06
QBC CENTRIFUGAL HEMATOLOGY CONTROL (K954137)R&D Systems, Inc.1995-10-06
COULTER Z 1 (K952308)Coulter Corp.1995-10-06
QBC ACCUTUBE (K953340)Becton Dickinson Diagnostic Instrument Systems1995-10-05
POSITIVE LUPUS ANTICOAGULANT PLASMA (K945856)George King Bio-Medical, Inc.1995-10-05
AVL OMNI ANALYZER (K954018)Avl Scientific Corp.1995-10-05
ABBOTT VISION HEMOGLOBIN (MODIFICATION) (K953221)Abbott Laboratories1995-09-29
HEPARIN CONTROL KIT (K943520)American Bioproducts Co.1995-09-26
THE HEPANORM HBPM/LMWH KIT (K943514)American Bioproducts Co.1995-09-26
HBPM/LMWH CONTROL KIT (K943519)American Bioproducts Co.1995-09-26
SPECTROLYSE ANTIPLASMIN KIT (K941752)Biopool AB1995-09-25
QBC ACCUTUBE (K945205)Becton Dickinson Diagnostic Instrument Systems1995-09-25
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