meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
38
Latest Decision
1984-02-04

Clearances · page 34 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840011 RESOLVE-HB Isolab, Inc. GKA Class II 1984-02-04
K834051 PROTOPATH FACTOR VIII ASSAY American Dade GGP Class II 1984-02-04
K834301 THROMBOLYTIC ACTIVITY TEST Bio/Data Corp. GJA Class II 1984-02-04
K834571 FIBRINOGEN TEST Diatech, Inc. KQJ Class II 1984-02-04
K840114 COAGULATION FACTOR DEFICIENT PLASMA Medical Specialties Laboratories GGP Class II 1984-02-04
K834050 PROTOPATH FACTOR IX ASSAY American Dade GGP Class II 1984-02-04
K834086 CONTACT-K APTT REAGENT Pacific Hemostasis GGN Class II 1984-02-03
K833929 WHITE BLOOD CELLS HUMAN TAND B Control Diagnostics LIZ Class II 1984-02-03
K833890 COATEST ANTIPLASMIN Kabivitrum, Inc. LGP Class II 1984-01-30
K834527 THROMBO PLUS W. Sarstedt, Inc. GGK Class I 1984-01-30
K833891 COATEST HEPARIN Kabivitrum, Inc. KFF Class II 1984-01-30
K833892 COATEST FACTOR VIII Kabivitrum, Inc. GGP Class II 1984-01-30
K833971 QUICK-COUNT Seragen Diagnostics, Inc. GKL Class II 1984-01-30
K834026 RDW PARAMETER FOR THE TECHNICON H6000 Technicon Instruments Corp. GKL Class II 1984-01-30
K834297 PROPPER SERACULT Propper Mfg. Co., Inc. KHE Class II 1984-01-27
K834294 ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB Emd Chemicals, Inc. LCP Class II 1984-01-24
K833772 AUTO AIC ANALYZER SYSTEM Helena Laboratories LCP Class II 1984-01-18
K833618 ORTHO ELT-8/DS HEMATOLOGY ANALYZER Ortho Diagnostic Systems, Inc. GKZ Class II 1984-01-13
K834456 HELENA BIO STRIP OB Helena Laboratories KHE Class II 1984-01-13
K833600 COULTER COUNTER MODEL S-PLUS V Coulter Electronics, Inc. GKZ Class II 1984-01-10
K833708 COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE Worthington Diagnostic Systems LKZ Class II 1984-01-04
K834043 MSI-HC HEMATOLOGY CONTROL Medical Specialties, Inc. JPK Class II 1984-01-03
K833805 GLYCOGLOBIN KIT Endocrine Sciences Products LCP Class II 1984-01-03
K833563 HC PLUS Coulter Electronics, Inc. JPK Class II 1984-01-03
K834031 FACTOR II DEFICIENT SUBSTRATE PLASMA Helena Laboratories GGP Class II 1983-12-16
K833678 HEMATOLOGY WRIGHT'S STAIN PACK J.S. Medical Assoc. IAF Class I 1983-11-25
K833677 QUICK STAIN WRIGHT'S GIEMSA W/BUFF J.S. Medical Assoc. HYF Class I 1983-11-25
K833665 HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK J.S. Medical Assoc. HYF Class I 1983-11-25
K833463 CLEX Dextran Products, Ltd. KIS Class I 1983-11-21
K832864 COLOSCREEN V.P.I. Helena Laboratories KHE Class II 1983-11-21
K833424 VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 Sigma Chemical Co. HYO Class I 1983-11-03
K833272 THROMBOPLASTIN - FS American Dade JPA Class II 1983-11-03
K833352 GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL Warner-Lambert Co. GIL Class II 1983-11-03
K833394 MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE Sigma Chemical Co. KIT Class I 1983-11-03
K833358 MRC-5 CELLS Biocon, Inc. KIR Class I 1983-11-03
K833356 GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL Helena Laboratories LCP Class II 1983-11-03
K833444 LYSING & HEMOGLOBIN S-REAGENT J & S Jasins & Sayles Associates, Inc. GGK Class I 1983-11-03
K833389 MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM Sigma Chemical Co. KIT Class I 1983-11-03
K833360 HEP-2 CELLS Biocon, Inc. KIR Class I 1983-11-03
K833392 WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE Sigma Chemical Co. KIT Class I 1983-11-03
K833391 LACTALBUMIN HYDROLYSATE MED. W/HANKS Sigma Chemical Co. KIT Class I 1983-11-03
K833390 TYRODE'S SALT SOLUTION W/SODIUM BICAR Sigma Chemical Co. KIT Class I 1983-11-03
K833359 WI-38 CELLS Biocon, Inc. KIR Class I 1983-11-03
K833443 ISOTONIC BLOOD CELL DILUENT J & S Jasins & Sayles Associates, Inc. GIF Class I 1983-11-03
K833393 ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM Sigma Chemical Co. KIT Class I 1983-11-03
K833388 IRON STAIN PROCEDURE HT20 Sigma Chemical Co. LED Class I 1983-10-31
K833167 TRICHROME STAIN LG SOLUTION Sigma Chemical Co. LED Class I 1983-10-31
K833273 MASSON TRICHROME STAIN HT15 Sigma Chemical Co. ICN Class I 1983-10-31
K833260 STAIN PACK FOR AEROSPRAY SLIDE STAINER Wescor, Inc. IAF Class I 1983-10-28
K832771 ERYTHROCYTE TEST Bio-Analytics Laboratories, Inc. LKZ Class II 1983-10-28
K833165 FISHERS MED. FOR LEUKEMIC CELLS-MICE Sigma Chemical Co. KIT Class I 1983-10-28
K833169 MEM W/L-GLUTAMINE W/O SODIUM BICARBON Sigma Chemical Co. KIT Class I 1983-10-28
K832020 HEMOCUE PHOTOMETER TECHNICAL MANUAL Aktiebolaget Leo Diagnostics GKR Class II 1983-10-28
K833163 MEM-EAGLE W/EARLES SALTS W/IVEAA Sigma Chemical Co. KIT Class I 1983-10-28
K833168 MEM-EAGLE-W/EARLES SALTS W/NEAA & Sigma Chemical Co. KIT Class I 1983-10-28
K833164 L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 Sigma Chemical Co. KIT Class I 1983-10-27
K832116 ATAC 4700 HEMATOLOGY CELL COUNTER Turpen Laboratory Systems, Inc. GIF Class I 1983-10-20
K833130 TRI-COUNT 7 Hematology Marketing Assoc. JPK Class II 1983-10-20
K832428 PLATELET AGGREGATION REAGENT SET Helena Laboratories GHR Class II 1983-10-20
K832890 HEMACOMP 7 OR HEMATIL 7 Texas Intl. Laboratories, Inc. GKL Class II 1983-10-19
K832189 HEMOCHRON THROMBOCHRONOMETER International Technidyne Corp. JBP Class II 1983-10-14
K833016 TISSUE TRANSPORT MEDIUM Northern Scientific, Inc. KIT Class I 1983-10-14
K832427 EASYTOUCH TROMBOPLASTIN REAGENT Worthington Diagnostic Systems GJS Class II 1983-10-14
K832953 MUCICARMINE STAIN, #HT30 Sigma Chemical Co. HZC Class I 1983-09-29
K832930 SPINNER SALT SOLUTION S-6011 W/EARLES Sigma Chemical Co. KIT Class I 1983-09-29
K832947 ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO Ortho Diagnostic Systems, Inc. KIR Class I 1983-09-29
K832592 DIACROM * ATIII Wellcome Diagnostics JBQ Class II 1983-09-29
K832372 DIACROM * FACTOR X KIT HA31 Wellcome Diagnostics GGP Class II 1983-09-29
K832836 BASAL MED. #B9763 W/HANKS SALTS W/L-G Sigma Chemical Co. KIT Class I 1983-09-29
K832929 RISTOCETIN PLATELET AGGREGA-REAGENT TEST Sigma Chemical Co. JBX Class II 1983-09-29
K832373 DIACROM * HEPARIN Wellcome Diagnostics KFF Class II 1983-09-29
K832841 NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM Sigma Chemical Co. KIT Class I 1983-09-29
K832842 DULBECCOS MODIFIED EAGLES MEDIUM D5648 Sigma Chemical Co. KIT Class I 1983-09-29
K832775 A-GENT GLYCOSYLATED HEMOGLOBIN Abbott Laboratories LCP Class II 1983-09-29
K832835 DULBECCOS PHOSPHATE BUFFERED SALINE Sigma Chemical Co. KIT Class I 1983-09-29
K832837 NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA Sigma Chemical Co. KIT Class I 1983-09-26
K832750 EASYTOUCH HEMOGLOBIN REAGENT Worthington Diagnostic Systems KHG Class II 1983-09-26
K832838 EARLES BALANCED SALT MIXTURE #E6132 Sigma Chemical Co. KIT Class I 1983-09-26
K832840 MINIMUM ESSENTIAL MED. EAGLE M4642 W/ Sigma Chemical Co. KIT Class I 1983-09-26
K832643 CELL-DYN 900 HEMATOLOGY ANALYZER Abbott Diagnostics GKL Class II 1983-09-26
K832839 HANKS BALANCED SALT MIXTURE H6136 Sigma Chemical Co. KIT Class I 1983-09-26
K832688 DULBECCO'S MODIFIED EAGLE #D5523- Sigma Chemical Co. KIT Class I 1983-09-12
K832687 BASAL MED. EAGLE #B9888 W/L-GLUTAMINE Sigma Chemical Co. KIT Class I 1983-09-12
K832627 TECHNICON H6000 SYSTEM Technicon Instruments Corp. GKL Class II 1983-09-12
K832496 BIO SURE STAIN Helena Laboratories IDA Class I 1983-09-12
K832689 MCCOY'S 5A #M4892 W/L-GLUTAMINE AND Sigma Chemical Co. KIT Class I 1983-09-12
K832690 MINIMUM ESSENTIAL MED. EAGLE M0268 Sigma Chemical Co. KIT Class I 1983-09-12
K832420 FACS ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1983-09-01
K832578 MONOJET SAMPLETTE ADAPTERS Sherwood Medical Co. GIO Class I 1983-08-31
K832114 COATEST FACTOR X Kabivitrum, Inc. GGP Class II 1983-08-26
K832087 TITAN GEL GLYCO-HEME SYSTEM Helena Laboratories LCP Class II 1983-08-24
K832225 ORTHO ABNORMAL COAGULATION LEVEL I/II Ortho Diagnostic Systems, Inc. JPA Class II 1983-08-12
K832182 LYSING REAGENT Omega Medical Diagnostics GGK Class I 1983-08-12
K832268 RABBIT ANTI-HUMAN ANTITHROMBIN III Gelco Diagnostics, Inc. JBQ Class II 1983-08-12
K831961 IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN Kent Laboratories, Inc. JBQ Class II 1983-08-11
K831053 QUANTIGEN T & B CELL ASSAY Bio-Rad LIZ Class II 1983-08-08
K831837 CLINOVATIVE II DIAGNOSTIC KIT Pierce Chemical Co. LCP Class II 1983-08-01
K831814 CALIBRATION STANDARD-HEMOGLOBIN United Diagnostics, Inc. KRZ Class II 1983-07-28
K831871 SICKLE-HEME A/S CONTROLS & A/A CONTROL Anco Medical Reagents & Assoc. GHM Class II 1983-07-28
K831813 CO-OXIMETER CONTROL United Diagnostics, Inc. KHG Class II 1983-07-28

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