meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
49
Latest Decision
1983-07-26

Clearances · page 35 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K831271 ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG Ortho Diagnostic Systems, Inc. GKZ Class II 1983-07-26
K831368 CELL-DYN 400 HEMOTOLOGY ANALYZER Abbott Diagnostics GKL Class II 1983-07-18
K831872 CALIBRATOR 282 Bionostics, Inc. KRZ Class II 1983-07-18
K831502 NEPHROLYTE Flaitron Laboratories, Inc. KFC Class I 1983-07-18
K832038 CELL-DYN 300 HEMATOLOGY ANALYZER Abbott Diagnostics GKL Class II 1983-07-18
K831686 CHLAMYDIA OVERBY MEDIA Viromed Laboratories, Inc. KIT Class I 1983-07-07
K830919 OCCULT-ALERT Beta Med Pharmaceuticals, Inc. KHE Class II 1983-07-07
K831685 SF REFEEDING MEDIA Viromed Laboratories, Inc. KIT Class I 1983-07-06
K831681 HEP-2 CELLS Viromed Laboratories, Inc. KIR Class I 1983-07-06
K831745 BASAL MEDIUM EAGLE W/EARLES SALTS, & Sigma Chemical Co. KIT Class I 1983-07-06
K831679 MRC-5 CELLS Viromed Laboratories, Inc. KIR Class I 1983-07-06
K831684 CYNOMOLGUS MONKEY KIDNEY CELLS SV5 Viromed Laboratories, Inc. KIR Class I 1983-07-06
K831704 TECHNICON H6000 SYSTEM CONTROL Technicon Instruments Corp. JPK Class II 1983-07-06
K831683 SF CELLS Viromed Laboratories, Inc. KIR Class I 1983-07-06
K831680 VERO CELLS Viromed Laboratories, Inc. KIR Class I 1983-07-06
K831682 MCCOY CELLS Viromed Laboratories, Inc. KIR Class I 1983-07-06
K831605 HEMATOLOGY PAK Mercedes Scientific Co., Inc. IAF Class I 1983-06-30
K831478 LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN Bio-Rad LCP Class II 1983-06-22
K831519 RPMI-1640 MEDIUM W/L-GLUTAMINE & Sigma Chemical Co. KIT Class I 1983-06-22
K831558 E-Z PREP Coulter Electronics, Inc. GKJ Class I 1983-06-16
K831306 HEMACAL Hematology Marketing Assoc. KRZ Class II 1983-06-16
K830935 HEMOGLOBIN ALC BY COLUMN TEST Bio-Rad LCP Class II 1983-06-16
K831618 HEMOGLOBIN REAGENT Omega Medical Diagnostics GKR Class II 1983-06-16
K831617 DILUENT Omega Medical Diagnostics GIF Class I 1983-06-16
K830864 WHITE BLOOD CELL CONTROL Control Diagnostics JPK Class II 1983-06-15
K831318 COMPUR* M1100 HEMATRCRIT SYSTEM Worthington Diagnostic Systems JPI Class II 1983-06-08
K831297 PROTOTRO/PROTEOLYTIC ENZYME CONTROL American Dade JBQ Class II 1983-06-08
K831140 DADE HEMATOLOGY CALIBRATOR American Dade KRX Class II 1983-06-08
K831060 TRICHROME STAIN American Micro Scan JTS Class I 1983-06-08
K830665 HEPCOL SYSTEM B-10 & B-10-P Hemotec, Inc. JOX Class II 1983-06-08
K831131 CASE WRIGHT-GIEMSA STAIN PAK Case Instruments HYF Class I 1983-06-08
K831090 HEMATOXYLIN GILL FORMULATION IX#56016 Accra Laboratories, Inc. HYJ Class I 1983-06-08
K831094 PARA LASAR Streck Laboratories, Inc. JPK Class II 1983-06-08
K831055 HEMOGLOBIN ELECTROPHORESIS METH ON THE- Olympus Corp. JBO Class II 1983-06-08
K830749 PLATELET AGGREGOMETER Chrono-Log Corp. JBX Class II 1983-05-16
K830507 SYSMEX CC-170 Toa Medical Electronics USA, Inc. GKL Class II 1983-05-13
K830508 SYSMEX CC-180 Toa Medical Electronics USA, Inc. GKL Class II 1983-05-09
K830505 SYSMEX CC-130 Toa Medical Electronics USA, Inc. GKL Class II 1983-05-09
K830506 SYSMEX CC-150 Toa Medical Electronics USA, Inc. GKL Class II 1983-05-09
K831195 WESTERGREN DISPETTE FOR ESR Ulster Scientific, Inc. JPH Class I 1983-05-09
K830804 LABILE REMOVING HEMOLYZING REAGENT Corning Medical & Scientific JBD Class II 1983-05-04
K831079 LIQUIPETTE The Kendall Company Div. of Tyco Healthcare Group GJG Class I 1983-04-28
K830451 QBC CENTRIFUGAL HEMATOLOGY SYS Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1983-04-27
K830180 REFEREE BRAND CO-OXIMETER REAGENTS Analytical Products, Inc. KHG Class II 1983-04-08
K830331 LIQUID THROMBOPLASTIN REAGENT Helena Laboratories GJS Class II 1983-04-05
K830590 CORNING 2500 CO-OXIMETER Corning Medical & Scientific KHG Class II 1983-04-05
K830320 ACTIVAT-PARTIAL THROMBO-PLASTIN Helena Laboratories GGW Class II 1983-04-05
K830578 MICROHEMATOCRIT READER Fisher Scientific Co., LLC JPI Class II 1983-03-24
K830542 HEMAQUIK II STAINING SOLUTION #55961 Accra Laboratories, Inc. IAF Class I 1983-03-17
K830645 BLEEDING TIME DEVICE DISPOSABLE American Dade JCA Class II 1983-03-17
K830223 FECAL OCCULT SLIDE TEST KIT Cambridge Chemical Products, Inc. KHE Class II 1983-03-07
K830188 OSMOCEL + Hematology Marketing Assoc. GIF Class I 1983-03-01
K823886 PROFILE 750 BLOOD CELL COUNTER Mallinckrodt Critical Care GKL Class II 1983-03-01
K830186 LYSIS + Hematology Marketing Assoc. GGK Class I 1983-02-28
K830127 QUIK-DIP BLOOD STAIN Mercedes Scientific Co., Inc. IAF Class I 1983-02-15
K823900 GLUCOSE-6-PHOSPHATE DEHYDROGENASE Alladin Diagnostic, Inc. KQE Class II 1983-02-07
K823930 HEMATOLOGY QUALITY CONTROL MIXTURE Fisher Scientific Co., LLC GJP Class II 1983-02-01
K823869 GLYCO HB QUIK COLUMN PROCEDURE Helena Laboratories LCP Class II 1983-02-01
K823870 BETA THALQUIK COLUMN #5341 Helena Laboratories JPD Class II 1983-02-01
K823761 ERYTHROCYTE & STAND SEDIMENT. RATE TUBE Cordis Corp. JPH Class I 1983-01-21
K823558 MICRO-HEMATOCRIT CENTRIFUGE 335/336 Fisher Scientific Co., LLC JPI Class II 1983-01-21
K823453 VON WILLEBRAND FACTOR ASSAY General Diagnostics GGP Class II 1983-01-21
K823794 CONTROL TM 8 General Diagnostics GLQ Class II 1983-01-14
K823388 TENS MAX Fujisawa Electronics Co. GFK Class II 1983-01-08
K823587 UNI-CELL Medical Specialties Laboratories GLQ Class II 1983-01-05
K823522 DILULAB 230 Innovative Medical Systems, Inc. GKH Class I 1982-12-28
K823329 PAPINCOLABU STAIN EA-36/50/65 & OG-6 Accra Laboratories, Inc. HZL Class I 1982-12-28
K823355 COULTER-COUNTER #S PLUS IV & LYSE S +D Coulter Electronics, Inc. GKZ Class II 1982-12-28
K823328 HARRIS HEMATOXYLIN Accra Laboratories, Inc. HYK Class I 1982-12-28
K823498 PARA 12 Streck Laboratories, Inc. GLQ Class II 1982-12-28
K823344 HEMATOLOGY ANALYZER Abbott Diagnostics GKL Class II 1982-12-28
K823368 DADE ESR KIT American Dade JPH Class I 1982-12-28
K823520 FIBROSYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKQ Class I 1982-12-28
K823267 FACTOR VIII RELATED ANTIGEN ROCKET EID Helena Laboratories GGP Class II 1982-12-28
K823363 COUNT-10 STAIN V-Tech, Inc. LEE Class I 1982-12-15
K823131 KOAGULAB 40-A AUTOMATED COAGULATION SYS Ortho Diagnostic Systems, Inc. KQG Class II 1982-12-09
K822867 GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY Isolab, Inc. LCP Class II 1982-12-03
K822733 SIGMA REAGENT SYSTEM NO. 885 Sigma Chemical Co. JBE Class II 1982-12-03
K823138 CELL SCRAPER Corning Costar Corp. KJA Class I 1982-11-29
K823060 HEMOGLOBIN REAGENT Biorent Diagnostic, Inc. KHG Class II 1982-11-22
K822327 CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT Interscience, Inc. KRZ Class II 1982-11-16
K822977 HEMOGLOBIN ALC BY COLUMN TEST Bio-Rad LCP Class II 1982-11-16
K822324 RED CELL LYSING REAGENT 78N 1915-1 Interscience, Inc. GGK Class I 1982-11-08
K822982 MIDAS 100 HEMACOLOR STAIN #66030 Emd Chemicals, Inc. HYB Class I 1982-10-27
K822981 MIDAS 1000 WRIGHT GIEMSA STAIN #66020 Emd Chemicals, Inc. IAF Class I 1982-10-27
K822980 MIDAS 1000 WRIGHT STAIN #66010 Emd Chemicals, Inc. IAF Class I 1982-10-27
K822823 HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT Eko Scann AB LKM Class II 1982-10-18
K822325 BLOOD CELL DILUENT 78N 1913 Interscience, Inc. GIF Class I 1982-10-18
K822758 SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY Toa Medical Electronics USA, Inc. GKL Class II 1982-10-18
K822731 HEMOTECT Bio-Chem Laboratories KHE Class II 1982-10-18
K822782 ACUSCREEN Ortho Diagnostic Systems, Inc. GGW Class II 1982-10-08
K821884 GASTROCCULT TM Smithkline Diagnostics, Inc. KHE Class II 1982-10-08
K822716 UNIVERSAL CENTRIFUGE Biodynamics Corp. JPI Class II 1982-09-30
K822521 AUTOMATED BLOOD CELL SEPARATOR Cryosan, Inc. GKT Class II 1982-09-30
K822501 CDL ISOTONIC DILUENT Connecticut Diagnostics, Ltd. GIF Class I 1982-09-17
K822504 CDL AUTO-LYSING REAGENT Connecticut Diagnostics, Ltd. GGK Class I 1982-09-17
K822500 CDL LYSING REAGENT Connecticut Diagnostics, Ltd. GGK Class I 1982-09-17
K821803 QBC CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKG Class II 1982-09-14
K822466 THROMBIN TIME TEST American Dade GJA Class II 1982-09-14
K822445 HCT CENTRIFUGE Boehringer Mannheim Corp. GKG Class II 1982-09-14

4,197 clearances in the Hematology panel. Data: openFDA.