Hematology
4,194 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| NEPHROLYTE (K831502) | Flaitron Laboratories, Inc. | 1983-07-18 |
| CELL-DYN 300 HEMATOLOGY ANALYZER (K832038) | Abbott Diagnostics | 1983-07-18 |
| CHLAMYDIA OVERBY MEDIA (K831686) | Viromed Laboratories, Inc. | 1983-07-07 |
| OCCULT-ALERT (K830919) | Beta Med Pharmaceuticals, Inc. | 1983-07-07 |
| HEP-2 CELLS (K831681) | Viromed Laboratories, Inc. | 1983-07-06 |
| CYNOMOLGUS MONKEY KIDNEY CELLS SV5 (K831684) | Viromed Laboratories, Inc. | 1983-07-06 |
| SF REFEEDING MEDIA (K831685) | Viromed Laboratories, Inc. | 1983-07-06 |
| VERO CELLS (K831680) | Viromed Laboratories, Inc. | 1983-07-06 |
| MCCOY CELLS (K831682) | Viromed Laboratories, Inc. | 1983-07-06 |
| SF CELLS (K831683) | Viromed Laboratories, Inc. | 1983-07-06 |
| BASAL MEDIUM EAGLE W/EARLES SALTS, & (K831745) | Sigma Chemical Co. | 1983-07-06 |
| MRC-5 CELLS (K831679) | Viromed Laboratories, Inc. | 1983-07-06 |
| TECHNICON H6000 SYSTEM CONTROL (K831704) | Technicon Instruments Corp. | 1983-07-06 |
| HEMATOLOGY PAK (K831605) | Mercedes Scientific Co., Inc. | 1983-06-30 |
| LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN (K831478) | Bio-Rad | 1983-06-22 |
| RPMI-1640 MEDIUM W/L-GLUTAMINE & (K831519) | Sigma Chemical Co. | 1983-06-22 |
| HEMOGLOBIN REAGENT (K831618) | Omega Medical Diagnostics | 1983-06-16 |
| E-Z PREP (K831558) | Coulter Electronics, Inc. | 1983-06-16 |
| HEMOGLOBIN ALC BY COLUMN TEST (K830935) | Bio-Rad | 1983-06-16 |
| HEMACAL (K831306) | Hematology Marketing Assoc. | 1983-06-16 |
| DILUENT (K831617) | Omega Medical Diagnostics | 1983-06-16 |
| WHITE BLOOD CELL CONTROL (K830864) | Control Diagnostics | 1983-06-15 |
| DADE HEMATOLOGY CALIBRATOR (K831140) | American Dade | 1983-06-08 |
| PROTOTRO/PROTEOLYTIC ENZYME CONTROL (K831297) | American Dade | 1983-06-08 |
| PARA LASAR (K831094) | Streck Laboratories, Inc. | 1983-06-08 |
| COMPUR* M1100 HEMATRCRIT SYSTEM (K831318) | Worthington Diagnostic Systems | 1983-06-08 |
| HEMATOXYLIN GILL FORMULATION IX#56016 (K831090) | Accra Laboratories, Inc. | 1983-06-08 |
| HEPCOL SYSTEM B-10 & B-10-P (K830665) | Hemotec, Inc. | 1983-06-08 |
| TRICHROME STAIN (K831060) | American Micro Scan | 1983-06-08 |
| CASE WRIGHT-GIEMSA STAIN PAK (K831131) | Case Instruments | 1983-06-08 |
| HEMOGLOBIN ELECTROPHORESIS METH ON THE- (K831055) | Olympus Corp. | 1983-06-08 |
| PLATELET AGGREGOMETER (K830749) | Chrono-Log Corp. | 1983-05-16 |
| SYSMEX CC-170 (K830507) | Toa Medical Electronics USA, Inc. | 1983-05-13 |
| SYSMEX CC-130 (K830505) | Toa Medical Electronics USA, Inc. | 1983-05-09 |
| SYSMEX CC-150 (K830506) | Toa Medical Electronics USA, Inc. | 1983-05-09 |
| SYSMEX CC-180 (K830508) | Toa Medical Electronics USA, Inc. | 1983-05-09 |
| WESTERGREN DISPETTE FOR ESR (K831195) | Ulster Scientific, Inc. | 1983-05-09 |
| LABILE REMOVING HEMOLYZING REAGENT (K830804) | Corning Medical & Scientific | 1983-05-04 |
| LIQUIPETTE (K831079) | The Kendall Company Div. of Tyco Healthcare Group | 1983-04-28 |
| QBC CENTRIFUGAL HEMATOLOGY SYS (K830451) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-04-27 |
| REFEREE BRAND CO-OXIMETER REAGENTS (K830180) | Analytical Products, Inc. | 1983-04-08 |
| ACTIVAT-PARTIAL THROMBO-PLASTIN (K830320) | Helena Laboratories | 1983-04-05 |
| CORNING 2500 CO-OXIMETER (K830590) | Corning Medical & Scientific | 1983-04-05 |
| LIQUID THROMBOPLASTIN REAGENT (K830331) | Helena Laboratories | 1983-04-05 |
| MICROHEMATOCRIT READER (K830578) | Fisher Scientific Co., LLC | 1983-03-24 |
| HEMAQUIK II STAINING SOLUTION #55961 (K830542) | Accra Laboratories, Inc. | 1983-03-17 |
| BLEEDING TIME DEVICE DISPOSABLE (K830645) | American Dade | 1983-03-17 |
| FECAL OCCULT SLIDE TEST KIT (K830223) | Cambridge Chemical Products, Inc. | 1983-03-07 |
| OSMOCEL + (K830188) | Hematology Marketing Assoc. | 1983-03-01 |
| PROFILE 750 BLOOD CELL COUNTER (K823886) | Mallinckrodt Critical Care | 1983-03-01 |
| LYSIS + (K830186) | Hematology Marketing Assoc. | 1983-02-28 |
| QUIK-DIP BLOOD STAIN (K830127) | Mercedes Scientific Co., Inc. | 1983-02-15 |
| GLUCOSE-6-PHOSPHATE DEHYDROGENASE (K823900) | Alladin Diagnostic, Inc. | 1983-02-07 |
| GLYCO HB QUIK COLUMN PROCEDURE (K823869) | Helena Laboratories | 1983-02-01 |
| BETA THALQUIK COLUMN #5341 (K823870) | Helena Laboratories | 1983-02-01 |
| HEMATOLOGY QUALITY CONTROL MIXTURE (K823930) | Fisher Scientific Co., LLC | 1983-02-01 |
| ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (K823761) | Cordis Corp. | 1983-01-21 |
| MICRO-HEMATOCRIT CENTRIFUGE 335/336 (K823558) | Fisher Scientific Co., LLC | 1983-01-21 |
| VON WILLEBRAND FACTOR ASSAY (K823453) | General Diagnostics | 1983-01-21 |
| CONTROL TM 8 (K823794) | General Diagnostics | 1983-01-14 |
| TENS MAX (K823388) | Fujisawa Electronics Co. | 1983-01-08 |
| UNI-CELL (K823587) | Medical Specialties Laboratories | 1983-01-05 |
| FIBROSYSTEM (K823520) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-12-28 |
| HARRIS HEMATOXYLIN (K823328) | Accra Laboratories, Inc. | 1982-12-28 |
| PARA 12 (K823498) | Streck Laboratories, Inc. | 1982-12-28 |
| FACTOR VIII RELATED ANTIGEN ROCKET EID (K823267) | Helena Laboratories | 1982-12-28 |
| HEMATOLOGY ANALYZER (K823344) | Abbott Diagnostics | 1982-12-28 |
| PAPINCOLABU STAIN EA-36/50/65 & OG-6 (K823329) | Accra Laboratories, Inc. | 1982-12-28 |
| DADE ESR KIT (K823368) | American Dade | 1982-12-28 |
| COULTER-COUNTER #S PLUS IV & LYSE S +D (K823355) | Coulter Electronics, Inc. | 1982-12-28 |
| DILULAB 230 (K823522) | Innovative Medical Systems, Inc. | 1982-12-28 |
| COUNT-10 STAIN (K823363) | V-Tech, Inc. | 1982-12-15 |
| KOAGULAB 40-A AUTOMATED COAGULATION SYS (K823131) | Ortho Diagnostic Systems, Inc. | 1982-12-09 |
| GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY (K822867) | Isolab, Inc. | 1982-12-03 |
| SIGMA REAGENT SYSTEM NO. 885 (K822733) | Sigma Chemical Co. | 1982-12-03 |
| CELL SCRAPER (K823138) | Corning Costar Corp. | 1982-11-29 |
| HEMOGLOBIN REAGENT (K823060) | Biorent Diagnostic, Inc. | 1982-11-22 |
| CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT (K822327) | Interscience, Inc. | 1982-11-16 |
| HEMOGLOBIN ALC BY COLUMN TEST (K822977) | Bio-Rad | 1982-11-16 |
| RED CELL LYSING REAGENT 78N 1915-1 (K822324) | Interscience, Inc. | 1982-11-08 |
| MIDAS 1000 WRIGHT GIEMSA STAIN #66020 (K822981) | Emd Chemicals, Inc. | 1982-10-27 |
| MIDAS 1000 WRIGHT STAIN #66010 (K822980) | Emd Chemicals, Inc. | 1982-10-27 |
| MIDAS 100 HEMACOLOR STAIN #66030 (K822982) | Emd Chemicals, Inc. | 1982-10-27 |
| HEMOTECT (K822731) | Bio-Chem Laboratories | 1982-10-18 |
| BLOOD CELL DILUENT 78N 1913 (K822325) | Interscience, Inc. | 1982-10-18 |
| SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY (K822758) | Toa Medical Electronics USA, Inc. | 1982-10-18 |
| HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT (K822823) | Eko Scann AB | 1982-10-18 |
| GASTROCCULT TM (K821884) | Smithkline Diagnostics, Inc. | 1982-10-08 |
| ACUSCREEN (K822782) | Ortho Diagnostic Systems, Inc. | 1982-10-08 |
| UNIVERSAL CENTRIFUGE (K822716) | Biodynamics Corp. | 1982-09-30 |
| AUTOMATED BLOOD CELL SEPARATOR (K822521) | Cryosan, Inc. | 1982-09-30 |
| CDL LYSING REAGENT (K822500) | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| CDL ISOTONIC DILUENT (K822501) | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| CDL AUTO-LYSING REAGENT (K822504) | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| HCT CENTRIFUGE (K822445) | Boehringer Mannheim Corp. | 1982-09-14 |
| THROMBIN TIME TEST (K822466) | American Dade | 1982-09-14 |
| QBC CENTRIFUGAL HEMATOLOGY SYSTEM (K821803) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-14 |
| CONTROL DIAGNOSTICS PLATELET CONTROL (K821851) | Immunogenetics | 1982-09-02 |
| HEMATOXYLIN STAIN SOLUTION (K822352) | Fisher Scientific Co., LLC | 1982-08-16 |
| VOLU-SOL SINGLE DIFFERENTIAL STAIN (K822128) | Volu Sol Medical Industries | 1982-08-05 |
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