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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
37
Latest Decision
1985-11-05

Clearances · page 30 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854114 COULTER COUNTER MODEL T-660 Coulter Electronics, Inc. GKL Class II 1985-11-05
K851153 COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE Astral Medical Systems JPA Class II 1985-11-05
K854176 POLYCHROME IV STAIN Devetec, Inc. LED Class I 1985-10-31
K854121 MICRO-MAT SYSTEM Prevo Micro-Mat System GKJ Class I 1985-10-31
K854079 THROMBO SCREEN SICKLE CELL ASSAY SET Pacific Hemostasis GHM Class II 1985-10-31
K853896 GRAM STAIN KIT Sigma Diagnostics, Inc. JTS Class I 1985-10-22
K853803 FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB Z.L. Bocknek Laboratories, Inc. KIS Class I 1985-10-15
K852848 FDP ASSAY-20 TEST KIT American Bioproducts Co. GHH Class II 1985-10-10
K852992 PARA CHECK (AKA EIGHT CHECK-C) Streck Laboratories, Inc. JPK Class II 1985-10-10
K853429 COULTER COUNTER MODEL M5 Coulter Electronics, Inc. GKL Class II 1985-10-10
K853897 CITREX H Bio/Data Corp. GGW Class II 1985-10-10
K853789 ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR Hemotec, Inc. JPA Class II 1985-10-04
K853198 ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES Medical Device Consultants, Inc. JPA Class II 1985-10-04
K852520 ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. GHH Class II 1985-10-04
K852450 LODE COAGULOMETER MODEL LC-6 Lode Corp. JPA Class II 1985-09-30
K853776 MSI-HB HEMOGLOBIN CONTROL Medical Specialties, Inc. JPK Class II 1985-09-19
K852371 CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY Abbott Diagnostics GKZ Class II 1985-09-17
K852512 THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT Pacific Hemostasis GHH Class II 1985-09-17
K853634 CORNING CELL WELLS-MULTIPLE WELL PLATES Corning Medical & Scientific KIZ Class I 1985-09-16
K852372 CELL-DYN BRAND HEMATOLOGY REAGENTS Abbott Diagnostics JPK Class II 1985-09-03
K851943 COULTER VOLUME ADAPTER Coulter Electronics, Inc. GKL Class II 1985-08-30
K853461 COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA American Dade GGP Class II 1985-08-29
K853462 COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA American Dade GGP Class II 1985-08-29
K853441 FETAL BOVINE SERUM IN TRANSFER CONTAINER Newport Biosystems, Inc. KJA Class I 1985-08-26
K852532 NEWPORT MEDIA TRANSFER CONTAINER Newport Bio Systems KJA Class I 1985-08-22
K853241 HEMATOLOGY STAIN PACK Fisher Scientific Co., LLC IAF Class I 1985-08-19
K852986 GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN Clinical Technology Corp. LCP Class II 1985-08-19
K852492 COAGULATOR Med USA KQG Class II 1985-08-13
K853246 CALCIUM CHLORIDE Bio/Data Corp. JPA Class II 1985-08-13
K852843 GENERAL DIAGNOSTICS COAG-A-MATE XC Warner-Lambert Co. KQC Class I 1985-08-13
K853187 ACRIDINE ORANGE FLUORESCENT STAIN Advanced Medical Technology, Inc. IDC Class I 1985-08-13
K853081 AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET Advanced Medical Technology, Inc. KJK Class I 1985-08-13
K853203 ULTRACLONE ECL-01-2200 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1985-08-12
K852484 PLASTINEX Bio/Data Corp. GJS Class II 1985-08-12
K853076 CITREX I Bio/Data Corp. JPA Class II 1985-08-12
K852195 CEPHALINEX ACTIVATED PTT REAGENT Bio/Data Corp. GGW Class II 1985-08-12
K853078 CITREX III Bio/Data Corp. JPA Class II 1985-08-12
K852519 DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE E.I. Dupont DE Nemours & Co., Inc. JCO Class II 1985-08-12
K853077 CITREX II Bio/Data Corp. JPA Class II 1985-08-12
K852176 DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. GHH Class II 1985-08-12
K851736 COULTER CHANNELYZER 256 Coulter Electronics, Inc. GKL Class II 1985-07-30
K851843 OSMOCEL 3 Hematology Marketing Assoc. GIF Class I 1985-07-30
K851636 DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM Bio-Rad LCP Class II 1985-07-30
K851663 QUICK-COUNT HEMATOLOGY CONTROLS Seragen Diagnostics, Inc. JPK Class II 1985-07-23
K851669 MONITOR IV PLUS Helena Laboratories JOZ Class II 1985-07-23
K852554 SRT-SYSTEM Microwave Development, Inc. JPH Class I 1985-07-18
K851467 HEMOGLOBIN ANALYZER Awareness Technology, Inc. KHG Class II 1985-07-16
K852516 CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE Whittaker General Medical JPI Class II 1985-07-15
K852482 MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 Em Diagnostic Systems, Inc. JPI Class II 1985-07-15
K851508 NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS Nikon, Inc. LNJ Class II 1985-07-12
K852506 BIOGLAS MICROCARRIER BEAD Solohill Engineering, Inc. KJB Class I 1985-07-12
K852568 MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON Sigma Chemical Co. KIT Class I 1985-07-12
K852485 CELLGRO(ISCOVE'S MEDIUM) MODIFICATION Mediatech, Inc. KIT Class I 1985-07-12
K852475 CELLGRO WILLIAMS' MEDIUM E Mediatech, Inc. KIT Class I 1985-07-12
K852602 MCCOY'S 5A MEDIUM-LIQUID FORM Mediatech, Inc. KIT Class I 1985-07-12
K852395 MINK LUNG Viromed Laboratories, Inc. KIR Class I 1985-07-12
K851375 TRI-COUNT Hematology Marketing Assoc. JPK Class II 1985-07-12
K852394 MDCK Viromed Laboratories, Inc. KIR Class I 1985-07-12
K851432 HEMOGLOBIN Pointe Scientific, Inc., KHG Class II 1985-07-12
K852396 HEK Viromed Laboratories, Inc. KIR Class I 1985-07-12
K852016 LASER PLATELETCAL/MULTIPLE R&D Systems, Inc. KRY Class II 1985-07-09
K851280 DASS PACK Dass, Inc. GIF Class I 1985-07-05
K852373 AD150, AUTOMATED HEMATOLOGY DILUTOR Abbott Diagnostics GKH Class I 1985-07-05
K852136 PRECINORM HB Boehringer Mannheim Corp. GGM Class II 1985-07-05
K851320 SDI PREPAX DILUKIT M. Scientific Distributors, Inc. GIF Class I 1985-07-05
K852111 GLYCO-CHECK Thyroid Diagnostics, Inc. LCP Class II 1985-07-05
K851169 ELECTRA 800 AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. KQG Class II 1985-06-24
K851275 GIBCO MYCOTECT 189-5670 Gibco Laboratories Life Technologies, Inc. KIW Class I 1985-06-21
K850431 EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL Nms Pharmaceuticals, Inc. KHE Class II 1985-06-17
K852138 WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S Canyon Diagnostics, Inc. IAF Class I 1985-06-13
K851025 AGGRO/LINK COMPUTER INTERFACE Chrono-Log Corp. JBX Class II 1985-06-12
K852204 MCCOY GENCELLS Genus Diagnostics KIR Class I 1985-06-04
K852205 RMK GENCELLS CULTURE SYSTEM Genus Diagnostics KIR Class I 1985-06-04
K852206 HEP-2 GENCELLS Genus Diagnostics KIR Class I 1985-06-04
K852288 CELLGRO Mediatech, Inc. KIT Class I 1985-06-04
K851125 ACA PROTHROMBIN TIME ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. GJS Class II 1985-05-29
K851127 DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO E.I. Dupont DE Nemours & Co., Inc. JPA Class II 1985-05-29
K851126 ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC E.I. Dupont DE Nemours & Co., Inc. GGW Class II 1985-05-29
K851174 METACHROME Potomac Medical System LNJ Class II 1985-05-23
K851927 VERO GENCELLS Genus Diagnostics KIR Class I 1985-05-20
K851928 HEK GENCELLS Genus Diagnostics KIR Class I 1985-05-20
K851863 NCTC-135 MEDIUM N3262 Sigma Cell Culture Reagents KIT Class I 1985-05-20
K851862 MCDB 302 MEDIUM, M2021 Sigma Cell Culture Reagents KIT Class I 1985-05-20
K850354 SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS Toa Medical Electronics USA, Inc. GKZ Class II 1985-05-20
K851609 SFRE 199-2 MEDIUM, PRODUCTS NO. S2138 Sigma Chemical Co. KIT Class I 1985-05-15
K851604 CRCM-30 MEDIUM PRODUCT NO. C5030 Sigma Chemical Co. KIT Class I 1985-05-15
K851738 MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & Sigma KIT Class I 1985-05-15
K851605 SWIN'S S-77 MEDIUM, PRODUCTS S2513 Sigma Chemical Co. KIT Class I 1985-05-15
K851606 D-PBS, PRODUCTS NO. D5652 Sigma Chemical Co. KIT Class I 1985-05-15
K851737 MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & Sigma KIT Class I 1985-05-15
K851608 SFRE199-1 MEDIUM PRODUCT NO. S 2013 Sigma Chemical Co. KIT Class I 1985-05-15
K851607 MCDB 151 MEDIUM, PRODUCT NO. M6645 Sigma Chemical Co. KIT Class I 1985-05-15
K850755 CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 1985-05-13
K850171 SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS Toa Medical Electronics USA, Inc. GKL Class II 1985-05-13
K850592 PLATELET AGGREGATION REAGENT Chrono-Log Corp. JBX Class II 1985-05-13
K850391 PLASMA EXTRACTION SYSTEM Hans J. Brouwers & Assoc. JPI Class II 1985-05-10
K851561 WI-38 GENCELLS Genus Diagnostics KIR Class I 1985-05-10
K851562 MRC-5 GENCELLS Genus Diagnostics KIR Class I 1985-05-10
K851563 RK GENCELLS Genus Diagnostics KIR Class I 1985-05-10
K851545 ULTRACLONE ECL-01-800 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1985-05-10

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