Atlas FDA

Hematology

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

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RecordFirmDate
BACTIDROP INDIA INK (K920976)Remel Co.1992-06-09
BACTIDROP CALCOFLUOR WHITE (K920975)Remel Co.1992-06-09
HERMLE Z230H (K920207)Labnet Intl., Inc.1992-06-09
CASCADE 480 (K921363)Helena Laboratories1992-06-09
THROMBO-CALIBRATOR KIT (K921344)American Bioproducts Co.1992-06-09
AVK CONTROL I & II (K921665)American Bioproducts Co.1992-06-09
GLYCO-TEK AFFINITY COLUMN KIT (K921305)Helena Laboratories1992-06-09
PTT-LA TEST KIT (K921684)American Bioproducts Co.1992-06-09
BACTIDROP KOH (10%) (K920970)Remel Co.1992-06-09
UNICALIBRATOR KIT (K922021)American Bioproducts Co.1992-06-09
DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (K920895)Baxter Diagnostics, Inc.1992-06-04
CD-CHEX (K920997)Streck Laboratories, Inc.1992-05-31
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 (K920949)Heraeus Kulzer, Inc.1992-05-15
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA (K915411)Baxter Diagnostics, Inc.1992-05-11
THROMBIN CLOTTING TIME REAGENT (K920147)Helena Laboratories1992-05-01
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (K914256)Intl. Remote Imaging Systems1992-05-01
CRITSPIN MICRO-HEMATOCRIT (K920759)Stat-Spin Technologies1992-04-29
SYSMEX HEMATOLOGY SYSTEM ACCESSORIES (K920544)Toa Medical Electronics USA, Inc.1992-04-29
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA (K920981)Medical Diagnostic Technologies, Inc.1992-04-17
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (K915825)Fisher Scientific Co., LLC1992-03-11
COAGULATION ARPR,CAT.NO.5185 (K914949)Helena Laboratories1992-03-04
FIBRINOGEN CONTROL (K915462)Sigma Diagnostics, Inc.1992-03-04
ELLAGIC ACID APTT REAGENT (K915418)Helena Laboratories1992-02-14
SIMPLASTIN L (K915746)Organon Teknika Corp.1992-02-12
HEMOCHRON ONESTEP APTT TEST (K915344)International Technidyne Corp.1992-02-11
SIMULTEST(TM) IMK-LYMPHOCYTE (K913192)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-06
HEMOPLUS (K913622)Sarstedt, Inc.1992-01-31
D-DIMER WELLCOTEST (HA10) (K915203)Wellcome Diagnostics1992-01-31
FIBRINOGEN FDP CONTROL (K915503)Cala Diagnostics1992-01-30
ACTIVATED PARTIAL THROMBOPLASTIN TIME (K915463)Sigma Diagnostics, Inc.1992-01-23
DIFFERENTIAL COUNTING BOARD (K915071)Biovation, Inc.1992-01-17
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY (K914818)Baxter Diagnostics, Inc.1992-01-15
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION (K914946)Helena Laboratories1992-01-13
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (K915441)Fisher Scientific Co., LLC1992-01-08
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES (K915163)Biopool AB1992-01-06
COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY (K915083)Kabi Pharmacia, Inc.1992-01-03
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT (K913667)The Binding Site, Ltd.1992-01-03
SYSMEX NE-1500, MODIFICATION (K914744)Toa Medical Electronics USA, Inc.1991-12-30
GAS TRAK CONNECT BLOOD GAS CONTROL (K914099)Biochemical Sciences, Inc.1991-12-18
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (K913384)Helena Laboratories1991-12-17
SPECTROLYSE PROTEIN C KIT (K914307)Biopool AB1991-12-09
ACS ULTRA-1 THROMBOPLASTIN (K913249)Analytical Control Systems, Inc.1991-12-04
FACSTRAK FLOW CYTOMETER (K914014)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-12-04
FRUCTOSAMINE ABG21 TEST SYSTEM (K913614)Boehringer Mannheim Corp.1991-12-02
EPO-RIA (K910481)Ramco Laboratories, Inc.1991-11-29
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE (K913879)R&D Systems, Inc.1991-11-27
ACS ULTRA-2 THROMBOPLASTIN (K913250)Analytical Control Systems, Inc.1991-11-27
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER (K913305)Unipath , Ltd.1991-11-22
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (K913427)Creative Laboratory Products, Inc.1991-11-19
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT (K912748)Binax, Inc.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD5 (K901188)Sigma Chemical Co.1991-10-31
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC (K910473)Coulter Immunology1991-10-31
MONOCLONAL ANTIBODY ANTI-CD2 (K901187)Sigma Chemical Co.1991-10-31
ACLAIMS-IS (K912085)W-Technology1991-10-31
MONOCLONAL ANTIBODY ANTI-CD19 (K901186)Sigma Chemical Co.1991-10-31
THROMBONOSTIKA F1.2 (K911434)Organon Teknika Corp.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD3 (K901189)Sigma Chemical Co.1991-10-31
HEMOCHRON(R) KACT (K913861)International Technidyne Corp.1991-10-18
FIBRINOSTIKA FBDP MICROELISA SYSTEM (K912876)Organon Teknika Corp.1991-10-09
HEMOCARD HEMOGLOBIN S (K911981)Isolab, Inc.1991-10-09
FIBRINOGEN DETERMINATION KIT (K913061)Sigma Diagnostics, Inc.1991-10-09
IL TEST PROCLOT ASSAY STYSTEM (K912711)Instrumentation Laboratory CO1991-10-09
STACLOT(R) PROTEIN S TEST KIT (K913424)American Bioproducts Co.1991-10-08
NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL (K913259)Nova Biomedical Corp.1991-10-08
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION (K912979)Labeltape Meditect, Inc.1991-10-04
LIATEST PROTEIN S KIT (K912468)American Bioproducts Co.1991-10-02
HEMATASTAT C-70B (K913128)Separation Technology, Inc.1991-09-23
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT (K905709)Beckman Instruments, Inc.1991-09-23
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS (K912087)Instrumentation Laboratory CO1991-09-19
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE (K913005)Remel Co.1991-09-16
SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER (K911626)Serono Baker Diagnostics System1991-09-13
SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER (K912494)Toa Medical Electronics USA, Inc.1991-09-10
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) (K912679)Baxter Healthcare Corp1991-09-10
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM (K911625)Heraeus Kulzer, Inc.1991-09-05
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED (K911777)Helena Laboratories1991-08-22
ARACHIDONIC ACID (K912774)Helena Laboratories1991-08-22
SPECTROLYSE PLASMINOGEN SK KIT (K912025)Biopool AB1991-08-22
PACKS-4 (TM) ANALYZER (K912201)Helena Laboratories1991-08-16
ACS LIQUID THROMBOPLASTIN (K912102)Analytical Control Systems, Inc.1991-08-09
SIMPLATE PEDIATRIC (K911745)Organon Teknika Corp.1991-08-09
SYSMEX F-310 (K911173)Toa Medical Electronics USA, Inc.1991-07-26
SYSMEX F-610 (K911172)Toa Medical Electronics USA, Inc.1991-07-26
SYSMEX F-810 (K910849)Toa Medical Electronics USA, Inc.1991-07-26
HEPARIN ADSORBENT (K912061)Sigma Diagnostics, Inc.1991-07-24
PX COULTER(R) CELL CONTROL (K912133)Coulter Electronics, Inc.1991-07-17
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION (K911995)International Technidyne Corp.1991-07-17
HEMOCHRON(R) APTT, MODIFICATION (K911994)International Technidyne Corp.1991-07-17
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (K911996)International Technidyne Corp.1991-07-17
HEPCON HMS WITH BODY SURFACE AREA CALCULATION (K911240)Hemotech, Inc.1991-07-17
HEMOGLOBIN REAGENT (K910745)Toa Medical Electronics USA, Inc.1991-07-11
ABL520 BLOOD GAS SYSTEM (K910827)Radiometer America, Inc.1991-07-09
COULTERCLONE (K911793)Coulter Immunology1991-07-09
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE (K912357)R&D Systems, Inc.1991-07-09
COLOCARE (K905798)Helena Laboratories1991-07-03
COLOSCREEN (K911075)Helena Laboratories1991-07-03
COULTER(R) MH010 (K911385)Coulter Electronics, Inc.1991-06-17
DADE(R) PROTEIN C ABNORMAL CONTRAL (K911885)Baxter Healthcare Corp1991-06-11
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (K911347)Bio-Rad1991-06-10
STAK-CHEX (K911582)Streck Laboratories, Inc.1991-05-28
ADP REAGENT (K910800)Helena Laboratories1991-05-20
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