meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
45
Latest Decision
1984-12-05

Clearances · page 32 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843352 COLOSCREEN SELF-TEST Helena Laboratories KHE Class II 1984-12-05
K843303 COULTER COUNTER MODEL M4 Coulter Electronics, Inc. GKL Class II 1984-12-05
K843608 CAPILLARY BLOOD COLLECTION TUBE Medical Technomics, Ltd. GIO Class I 1984-11-30
K841809 COUNT-A-PART PLUS Diagnostic Technology, Inc. JPK Class II 1984-11-30
K843202 HEPARIN CALIBRATOR ACA E.I. Dupont DE Nemours & Co., Inc. KFF Class II 1984-11-30
K843201 HEPARIN ACA ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. KFF Class II 1984-11-30
K843451 FACTOR XII DEFICIENT PLASMA B12D Sigma Chemical Co. GGP Class II 1984-11-19
K843438 FACTOR XI DEFICIENT PLASMA B11D Sigma Chemical Co. GGP Class II 1984-11-19
K843215 FACTOR IX DEFICIENT PLASMA, B9D - Sigma Chemical Co. GGP Class II 1984-11-19
K843310 FACTOR X DEFICIENT PLASMA, BLOD HUMAN Sigma Chemical Co. GGP Class II 1984-11-19
K843892 MICRO HEMATOCRIT CAPILLARY TUBES Abco Dealers, Inc. GIO Class I 1984-11-13
K843164 COULTER COUNTER MODEL ZM Coulter Electronics, Inc. GKL Class II 1984-11-13
K843962 CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1984-11-01
K843684 SIGMA SUDAN BLACK REAGENT 380-1 Sigma Chemical Co. HZZ Class I 1984-10-31
K843579 ULTRACLONE ECL-01-1100 Earl-Clay Laboratories, Inc. KIR Class I 1984-10-31
K843577 ULTRAXLONE ECL-01-1000 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-10-31
K843578 ULTRACLONE ECL-01-2100 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-10-31
K843919 SPOTTEST LOEFFLER METHYLENE BLUE STAIN Difco Laboratories, Inc. KFC Class I 1984-10-30
K843619 RETIC-SET R&D Systems, Inc. KQC Class I 1984-10-30
K843752 SIGMA PERIODIC ACID-SCHIFF STAIN 395 Sigma Chemical Co. HZT Class I 1984-10-30
K842818 CST Bd Becton Dickinson Vacutainer Systems Preanalytic JCF Class I 1984-10-23
K843207 REPTILASE -PC Bio/Data Corp. JCO Class II 1984-10-23
K844042 BLOOD DILUTION VIAL American Scientific Products GKL Class II 1984-10-23
K843093 RETIC-CHEX Streck Laboratories, Inc. JPK Class II 1984-10-23
K843863 ULTRACLONE ECL-01-1300 CELL LINE Earl-Clay Laboratories, Inc. KIT Class I 1984-10-17
K843864 ULTRACLONE ECL-01-1400 CELL LINE Earl-Clay Laboratories, Inc. KIT Class I 1984-10-17
K843862 ULTRACLONE ECL-01-900 CELL LINE Earl-Clay Laboratories, Inc. KIT Class I 1984-10-17
K842717 COBAS-FIBRO Roche Diagnostic Systems, Inc. JPA Class II 1984-10-17
K842689 GLYCO-TEK AFFINITY COLUMN Helena Laboratories LCP Class II 1984-10-15
K843425 HARRIS HEMATOXYLIN, MERCURY FREE, ACID Accra Laboratories, Inc. HYK Class I 1984-10-02
K843427 GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 Accra Laboratories, Inc. HZJ Class I 1984-10-02
K842617 VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT American Dade GGP Class II 1984-10-01
K842537 VON WILLEBRAND FACTOR ANTIGEN SCREEN American Dade ICF Class I 1984-10-01
K843629 FETAL BOVINE SERUM, F4884 STERILE GROWT Sigma Chemical Co. KIS Class I 1984-10-01
K842747 HYCEL DILUTOR, VARIOUS MODELS/MULTI R&D Systems, Inc. GKH Class I 1984-10-01
K843426 EOSIN Y 1% ALCOHOLIC Accra Laboratories, Inc. HYB Class I 1984-09-27
K843361 MINICAPS Medical Technomics, Ltd. GIO Class I 1984-09-21
K843362 RINGCAPS Medical Technomics, Ltd. GIO Class I 1984-09-21
K843429 GRAM STAIN SET W/STABILIZED IODINE Accra Laboratories, Inc. JTS Class I 1984-09-14
K842938 ACETIC ACID 1% V/V E K Ind., Inc. GGK Class I 1984-09-14
K842937 ACETIC ACID 2% V/V E K Ind., Inc. GGK Class I 1984-09-12
K842936 ACETIC ACID, 3% V/V E K Ind., Inc. GGK Class I 1984-09-12
K842935 ACETIC ACID, 5% V/V E K Ind., Inc. GGK Class I 1984-09-12
K842286 DIA T1, T2 & T3 Diatech, Inc. JPK Class II 1984-09-11
K842927 LIGHT GREEN SF 1% E K Ind., Inc. HYS Class I 1984-09-11
K842930 GOMORI'S TRICHROME STAIN E K Ind., Inc. LED Class I 1984-09-11
K842735 PAP STAIN EA-65 E K Ind., Inc. HZJ Class I 1984-09-11
K843050 GRAM STAIN Reagent Laboratory, Inc. JTS Class I 1984-09-11
K842739 PAP STAIN, EA-36 E K Ind., Inc. HZJ Class I 1984-09-11
K842933 CARBOL-FUCHSIN, ZIEHL-NEEDSEN E K Ind., Inc. ICL Class I 1984-09-11
K842919 SCHIFF REAGENT FUCHSIN-SULFUROUS ACID E K Ind., Inc. HZT Class I 1984-09-11
K842926 METHYLENE BLUE STAIN, LOEFFLER E K Ind., Inc. KFC Class I 1984-09-11
K842785 STAIN, METHYLENE BLUE-EOSIN Reagent Laboratory, Inc. KFC Class I 1984-09-11
K842928 JENNER BLOOD STAIN E K Ind., Inc. KJX Class I 1984-09-11
K842916 SUDAN IV HERXHEIMER E K Ind., Inc. KKK Class I 1984-09-11
K842925 MUCI-CARMINE STAIN, MAYER'S FORMULA E K Ind., Inc. HZC Class I 1984-09-11
K842152 SICKLING HEMOGLOBIN CONTROLS, NORMAL Isolab, Inc. GHM Class II 1984-09-09
K842921 REES & ECKER DILUTION FLUID E K Ind., Inc. GLG Class I 1984-09-07
K842924 ORANGE G, 1% E K Ind., Inc. HZH Class I 1984-09-07
K842929 HAYEM DILUTING FLUID E K Ind., Inc. GIF Class I 1984-09-07
K842917 SCHIFF REAGENT, PAS STAIN E K Ind., Inc. HZT Class I 1984-09-07
K843251 RD CELLS Viromed Laboratories, Inc. KIR Class I 1984-09-06
K842446 DILU-MATIC 140 Abbott Diagnostics GKH Class I 1984-09-06
K843252 AFRICAN GREEN SV 5/SV 40 Viromed Laboratories, Inc. KIR Class I 1984-09-06
K841736 IL TEST ANTITHROMBIN III ACTIVITY Instrumentation Laboratory CO JBQ Class II 1984-09-06
K843250 BHK-21 Viromed Laboratories, Inc. KIR Class I 1984-09-06
K840527 COLOTRAK OCCULT BLOOD TEST Breit Laboratories, Inc. KHE Class II 1984-09-05
K841852 AUTOLYZER 800 Geometric Data, Div. Smithkline Corp. GKZ Class II 1984-09-05
K842137 OCCULT BLOOD TEST Breit Laboratories, Inc. KHE Class II 1984-09-05
K843086 DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX Sigma Chemical Co. KIT Class I 1984-08-28
K842833 PMK PRIMARY MONKEY KIDNEY-CELLS Bartels Immunodiagnostic Supplies, Inc. KJR Class I 1984-08-28
K843085 RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA Sigma Chemical Co. KIT Class I 1984-08-28
K842834 HEP-2 CELLS Bartels Immunodiagnostic Supplies, Inc. KJR Class I 1984-08-28
K842776 MINIMUM ESSENTIAL MED W/L-GLUTAMINE Sigma Chemical Co. KIT Class I 1984-08-20
K842746 HYCEL ROTOR-MIXER AND/OR MULTI R&D Systems, Inc. KSQ Class I 1984-08-17
K842736 PAP STAIN, OG-6 E K Ind., Inc. HZJ Class I 1984-08-17
K842734 SAFRANIN STAIN E K Ind., Inc. HZS Class I 1984-08-17
K842775 MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB Sigma Chemical Co. KIT Class I 1984-08-17
K842740 DELAFIELD HEMATOXYLIN STAIN E K Ind., Inc. HYJ Class I 1984-08-17
K842738 PAP STAIN EA-50 E K Ind., Inc. HZJ Class I 1984-08-17
K842140 PICOSCAL BLOOD CELL COUNTER PS-4 Diagnostic Technology, Inc. GKL Class II 1984-08-16
K840904 ACCU-CULT FECAL OCCULT BLOOD TEST Applied Medical Devices, Inc. KHE Class II 1984-08-16
K842741 GILL HEMATOXYLIN STAIN E K Ind., Inc. HYJ Class I 1984-08-15
K842742 GIEMSA STAIN E K Ind., Inc. HYF Class I 1984-08-15
K843043 MED. 199 CATALOG M3769 W/EARLE'S SALT Sigma Chemical Co. KIT Class I 1984-08-14
K843044 MINIM. ESSENTIAL MED. EAGLE M4144 W/ Sigma Chemical Co. KIT Class I 1984-08-14
K840948 CLEAR POROUS PLASTIC-HYPOALLERGENIC Gainor Medical GKX Class II 1984-08-14
K842743 NEW METHYLENE BLUE N E K Ind., Inc. KFC Class I 1984-08-12
K842744 WRIGHT STAIN E K Ind., Inc. IAF Class I 1984-08-12
K843045 LACTALBUMIN HYDROLYSATE MED. CATALOG Sigma Chemical Co. KIT Class I 1984-08-12
K840903 HELENA COLOSCREEN SELF-TEST Helena Laboratories KHE Class II 1984-08-10
K842733 GRAM IODINE E K Ind., Inc. HYI Class I 1984-08-10
K842745 WRIGHT-GIEMSA QUICK STAIN E K Ind., Inc. IAF Class I 1984-08-10
K842955 SICKLE-HEME A/S HETEROZYGOUS CONTROL Michclone Associates, Inc. GHM Class II 1984-08-09
K842723 SALINE, 1.3% W/O PRESERVATIVE E K Ind., Inc. KIP Class I 1984-08-03
K842730 GENTIAN VIOLET E K Ind., Inc. ICF Class I 1984-08-03
K842724 SALINE 0.85% W/O PRESERVATIVE E K Ind., Inc. KIP Class I 1984-08-03
K842727 SUPERMOUNT E K Ind., Inc. LED Class I 1984-08-03
K842725 SALINE, 0.85%W/PRESERVATIVE E K Ind., Inc. KIP Class I 1984-08-03
K833369 EARLY DETECTOR Warner-Lambert Co. KHE Class II 1984-08-02

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