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Hematology

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

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RecordFirmDate
HEPARIN CALIBRATOR ACA (K843202)E.I. Dupont DE Nemours & Co., Inc.1984-11-30
HEPARIN ACA ANALYTICAL TEST PACK (K843201)E.I. Dupont DE Nemours & Co., Inc.1984-11-30
CAPILLARY BLOOD COLLECTION TUBE (K843608)Medical Technomics, Ltd.1984-11-30
FACTOR X DEFICIENT PLASMA, BLOD HUMAN (K843310)Sigma Chemical Co.1984-11-19
FACTOR IX DEFICIENT PLASMA, B9D - (K843215)Sigma Chemical Co.1984-11-19
FACTOR XI DEFICIENT PLASMA B11D (K843438)Sigma Chemical Co.1984-11-19
FACTOR XII DEFICIENT PLASMA B12D (K843451)Sigma Chemical Co.1984-11-19
MICRO HEMATOCRIT CAPILLARY TUBES (K843892)Abco Dealers, Inc.1984-11-13
COULTER COUNTER MODEL ZM (K843164)Coulter Electronics, Inc.1984-11-13
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE (K843962)R&D Systems, Inc.1984-11-01
ULTRAXLONE ECL-01-1000 CELL LINE (K843577)Earl-Clay Laboratories, Inc.1984-10-31
SIGMA SUDAN BLACK REAGENT 380-1 (K843684)Sigma Chemical Co.1984-10-31
ULTRACLONE ECL-01-1100 (K843579)Earl-Clay Laboratories, Inc.1984-10-31
ULTRACLONE ECL-01-2100 CELL LINE (K843578)Earl-Clay Laboratories, Inc.1984-10-31
SPOTTEST LOEFFLER METHYLENE BLUE STAIN (K843919)Difco Laboratories, Inc.1984-10-30
SIGMA PERIODIC ACID-SCHIFF STAIN 395 (K843752)Sigma Chemical Co.1984-10-30
RETIC-SET (K843619)R&D Systems, Inc.1984-10-30
CST (K842818)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-10-23
RETIC-CHEX (K843093)Streck Laboratories, Inc.1984-10-23
BLOOD DILUTION VIAL (K844042)American Scientific Products1984-10-23
REPTILASE -PC (K843207)Bio/Data Corp.1984-10-23
ULTRACLONE ECL-01-900 CELL LINE (K843862)Earl-Clay Laboratories, Inc.1984-10-17
ULTRACLONE ECL-01-1300 CELL LINE (K843863)Earl-Clay Laboratories, Inc.1984-10-17
COBAS-FIBRO (K842717)Roche Diagnostic Systems, Inc.1984-10-17
ULTRACLONE ECL-01-1400 CELL LINE (K843864)Earl-Clay Laboratories, Inc.1984-10-17
GLYCO-TEK AFFINITY COLUMN (K842689)Helena Laboratories1984-10-15
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (K843427)Accra Laboratories, Inc.1984-10-02
HARRIS HEMATOXYLIN, MERCURY FREE, ACID (K843425)Accra Laboratories, Inc.1984-10-02
VON WILLEBRAND FACTOR ANTIGEN SCREEN (K842537)American Dade1984-10-01
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT (K842617)American Dade1984-10-01
HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747)R&D Systems, Inc.1984-10-01
FETAL BOVINE SERUM, F4884 STERILE GROWT (K843629)Sigma Chemical Co.1984-10-01
EOSIN Y 1% ALCOHOLIC (K843426)Accra Laboratories, Inc.1984-09-27
MINICAPS (K843361)Medical Technomics, Ltd.1984-09-21
RINGCAPS (K843362)Medical Technomics, Ltd.1984-09-21
ACETIC ACID 1% V/V (K842938)E K Ind., Inc.1984-09-14
GRAM STAIN SET W/STABILIZED IODINE (K843429)Accra Laboratories, Inc.1984-09-14
ACETIC ACID 2% V/V (K842937)E K Ind., Inc.1984-09-12
ACETIC ACID, 3% V/V (K842936)E K Ind., Inc.1984-09-12
ACETIC ACID, 5% V/V (K842935)E K Ind., Inc.1984-09-12
LIGHT GREEN SF 1% (K842927)E K Ind., Inc.1984-09-11
PAP STAIN EA-65 (K842735)E K Ind., Inc.1984-09-11
SUDAN IV HERXHEIMER (K842916)E K Ind., Inc.1984-09-11
PAP STAIN, EA-36 (K842739)E K Ind., Inc.1984-09-11
MUCI-CARMINE STAIN, MAYER'S FORMULA (K842925)E K Ind., Inc.1984-09-11
CARBOL-FUCHSIN, ZIEHL-NEEDSEN (K842933)E K Ind., Inc.1984-09-11
METHYLENE BLUE STAIN, LOEFFLER (K842926)E K Ind., Inc.1984-09-11
SCHIFF REAGENT FUCHSIN-SULFUROUS ACID (K842919)E K Ind., Inc.1984-09-11
STAIN, METHYLENE BLUE-EOSIN (K842785)Reagent Laboratory, Inc.1984-09-11
JENNER BLOOD STAIN (K842928)E K Ind., Inc.1984-09-11
DIA T1, T2 & T3 (K842286)Diatech, Inc.1984-09-11
GRAM STAIN (K843050)Reagent Laboratory, Inc.1984-09-11
GOMORI'S TRICHROME STAIN (K842930)E K Ind., Inc.1984-09-11
SICKLING HEMOGLOBIN CONTROLS, NORMAL (K842152)Isolab, Inc.1984-09-09
REES & ECKER DILUTION FLUID (K842921)E K Ind., Inc.1984-09-07
SCHIFF REAGENT, PAS STAIN (K842917)E K Ind., Inc.1984-09-07
ORANGE G, 1% (K842924)E K Ind., Inc.1984-09-07
HAYEM DILUTING FLUID (K842929)E K Ind., Inc.1984-09-07
AFRICAN GREEN SV 5/SV 40 (K843252)Viromed Laboratories, Inc.1984-09-06
IL TEST ANTITHROMBIN III ACTIVITY (K841736)Instrumentation Laboratory CO1984-09-06
DILU-MATIC 140 (K842446)Abbott Diagnostics1984-09-06
RD CELLS (K843251)Viromed Laboratories, Inc.1984-09-06
BHK-21 (K843250)Viromed Laboratories, Inc.1984-09-06
OCCULT BLOOD TEST (K842137)Breit Laboratories, Inc.1984-09-05
AUTOLYZER 800 (K841852)Geometric Data, Div. Smithkline Corp.1984-09-05
COLOTRAK OCCULT BLOOD TEST (K840527)Breit Laboratories, Inc.1984-09-05
DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX (K843086)Sigma Chemical Co.1984-08-28
PMK PRIMARY MONKEY KIDNEY-CELLS (K842833)Bartels Immunodiagnostic Supplies, Inc.1984-08-28
RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA (K843085)Sigma Chemical Co.1984-08-28
HEP-2 CELLS (K842834)Bartels Immunodiagnostic Supplies, Inc.1984-08-28
MINIMUM ESSENTIAL MED W/L-GLUTAMINE (K842776)Sigma Chemical Co.1984-08-20
HYCEL ROTOR-MIXER AND/OR MULTI (K842746)R&D Systems, Inc.1984-08-17
SAFRANIN STAIN (K842734)E K Ind., Inc.1984-08-17
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB (K842775)Sigma Chemical Co.1984-08-17
DELAFIELD HEMATOXYLIN STAIN (K842740)E K Ind., Inc.1984-08-17
PAP STAIN EA-50 (K842738)E K Ind., Inc.1984-08-17
PAP STAIN, OG-6 (K842736)E K Ind., Inc.1984-08-17
ACCU-CULT FECAL OCCULT BLOOD TEST (K840904)Applied Medical Devices, Inc.1984-08-16
PICOSCAL BLOOD CELL COUNTER PS-4 (K842140)Diagnostic Technology, Inc.1984-08-16
GIEMSA STAIN (K842742)E K Ind., Inc.1984-08-15
GILL HEMATOXYLIN STAIN (K842741)E K Ind., Inc.1984-08-15
MED. 199 CATALOG M3769 W/EARLE'S SALT (K843043)Sigma Chemical Co.1984-08-14
CLEAR POROUS PLASTIC-HYPOALLERGENIC (K840948)Gainor Medical1984-08-14
MINIM. ESSENTIAL MED. EAGLE M4144 W/ (K843044)Sigma Chemical Co.1984-08-14
LACTALBUMIN HYDROLYSATE MED. CATALOG (K843045)Sigma Chemical Co.1984-08-12
WRIGHT STAIN (K842744)E K Ind., Inc.1984-08-12
NEW METHYLENE BLUE N (K842743)E K Ind., Inc.1984-08-12
WRIGHT-GIEMSA QUICK STAIN (K842745)E K Ind., Inc.1984-08-10
HELENA COLOSCREEN SELF-TEST (K840903)Helena Laboratories1984-08-10
GRAM IODINE (K842733)E K Ind., Inc.1984-08-10
SICKLE-HEME A/S HETEROZYGOUS CONTROL (K842955)Michclone Associates, Inc.1984-08-09
SALINE, 1.3% W/O PRESERVATIVE (K842723)E K Ind., Inc.1984-08-03
GENTIAN VIOLET (K842730)E K Ind., Inc.1984-08-03
SUPERMOUNT (K842727)E K Ind., Inc.1984-08-03
SALINE, 0.85%W/PRESERVATIVE (K842725)E K Ind., Inc.1984-08-03
SALINE 0.85% W/O PRESERVATIVE (K842724)E K Ind., Inc.1984-08-03
EARLY DETECTOR (K833369)Warner-Lambert Co.1984-08-02
TECHNICON TEST POINT ASSAYED HEMATOLOGY (K842109)Technicon Instruments Corp.1984-07-27
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (K842440)Anco Medical Reagents & Assoc.1984-07-27
TECHNICON H*1 SYSTEM (K842636)Technicon Instruments Corp.1984-07-27
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