meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
42
Latest Decision
1987-03-30

Clearances · page 28 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870493 NUTRIENT MIXTURE F-12 (HAM) (HEPES BUFFERED) N4388 Sigma Chemical Co. KIT Class I 1987-03-30
K870478 DULBECCO'S MOD. EAGLE MED. NUT. MIX. F-12 #D2906 Sigma Chemical Co. KIT Class I 1987-03-30
K870489 RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 Sigma Chemical Co. KIT Class I 1987-03-30
K870491 KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 Sigma Chemical Co. KIP Class I 1987-03-30
K870486 EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 Sigma Chemical Co. KIP Class I 1987-03-30
K870497 BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR Sigma Chemical Co. KIT Class I 1987-03-30
K870495 (DME) AUTO-MOD MODIFIED FOR AUTOCLAVING #D5280 Sigma Chemical Co. KIT Class I 1987-03-30
K870484 HANKS' BALANCED SALTS (HBSS) NO. H1387 Sigma Chemical Co. KIP Class I 1987-03-30
K871067 MSI HEMATOLOGY CONTROL + Medical Specialties, Inc. JPK Class II 1987-03-25
K870468 ADULT BOVINE SERUM Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K870463 DEFINED FETAL BOVINE SERUM #A-1111 Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K870464 CHARACTERIZED FETAL BOVINE SERUM #A-1115 Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K870466 DEFINED CALF BOVINE SERUM #A-2111 Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K870467 DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K870469 DEFINED EQUINE SERUM #A-3311 Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K870465 6/40 FETAL BOVINE SERUM #A-1110 Hyclone Laboratories, Inc. KIS Class I 1987-03-24
K871076 WINPETTE Ulster Scientific, Inc. JPH Class I 1987-03-23
K865055 DR.BRUNO LANGE MINI-HBA1 PHOTOMETER Diversa Corp. GKR Class II 1987-03-19
K870960 COAG-A-MATE(R) XC Organon Teknika Corp. JPA Class II 1987-03-17
K870233 CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER Abbott Diagnostics GKZ Class II 1987-03-17
K864955 CYTOSCAN Image Recognition Systems , Ltd. LNJ Class II 1987-03-16
K870363 HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD Trace Scientific , Ltd. KHG Class II 1987-03-16
K870511 CHART-TYPE MICRO HEMATOCRIT TUBE READER Norfolk Scientific, Inc. JPI Class II 1987-03-16
K870353 IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) American Dade GGP Class II 1987-02-10
K870354 IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) American Dade GGP Class II 1987-02-10
K864664 H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS Technicon Instruments Corp. KSA Class II 1987-02-06
K864534 ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. JPA Class II 1987-02-06
K864532 ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. JPA Class II 1987-02-06
K864396 LYMPHOCYTE MAINTENANCE MEDIUM Bioclinical Laboratory Services, Inc. KIT Class I 1987-02-02
K864480 IL TEST 84668-15, FACTOR VIII CONTROL PLASMA Instrumentation Laboratory CO GGP Class II 1987-01-21
K864646 SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE E.I. Dupont DE Nemours & Co., Inc. GKF Class II 1987-01-05
K864392 PROTIME AUTOMATE TEST KIT American Bioproducts Co. GJS Class II 1987-01-05
K864740 BONE MARROW COLLECTION MEDIUM Bioclinical Laboratory Services, Inc. KIT Class I 1987-01-05
K864497 COAGULATION EXTRINSIC DEFICIENT PLASMAS Instrumentation Laboratory CO GGP Class II 1987-01-05
K864481 COAGULATION INTRINSIC DEFICIENT PLASMAS Instrumentation Laboratory CO GGP Class II 1987-01-05
K864211 IL TEST 97575-15, HEPARIN ASSAY Instrumentation Laboratory CO KFF Class II 1987-01-05
K864776 A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1986-12-31
K864531 TISSUE GRAM STAIN Sigma Diagnostics, Inc. ICF Class I 1986-12-22
K862849 HEMOCCULT WIPE TEST Smithkline Diagnostics, Inc. KHE Class II 1986-12-09
K864283 SIMPLASTIN EXCEL Organon Teknika Corp. GJS Class II 1986-12-04
K864214 IL TEST 97574-15M, ANTITTHROMBIN III ASSASY Instrumentation Laboratory CO JBQ Class II 1986-11-25
K864271 IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA Instrumentation Laboratory CO JPA Class II 1986-11-25
K864213 IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY Instrumentation Laboratory CO LGP Class II 1986-11-25
K864334 ACUSYST-P (CELL CULTURE EQUIPMENT) Endotronics, Inc. KJH Class I 1986-11-24
K864274 THROMBOPLASTIN.R American Dade GJS Class II 1986-11-13
K864272 THROMBOPLASTIN.FS American Dade GJS Class II 1986-11-13
K864033 RAPID ACID FAST STAIN Sigma Diagnostics, Inc. KJY Class I 1986-11-13
K864273 THROMBOPLASTIN.C American Dade GJS Class II 1986-11-13
K861731 NATURAL DETECTOR SYSTEM U.S. Health Resources Corp. KHE Class II 1986-11-06
K863114 PIASTRINIT J. D. Assoc. GGK Class I 1986-11-06
K864021 TISSUE CULTURE FLASK Fenwal Laboratories KJA Class I 1986-10-29
K863224 HEMATALL-C PLUS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC JPK Class II 1986-10-29
K864074 ELASTIC STAIN Sigma Diagnostics, Inc. IAC Class I 1986-10-29
K864039 MICROHEMATOCRIT CENTRIFUGE Plaza Medical, Inc. GKF Class II 1986-10-29
K862775 ASSERACHROM B-TG KIT American Bioproducts Co. JBX Class II 1986-10-22
K863594 ACTIN FSL ACTIVATED PTT REAGENT American Dade GGW Class II 1986-10-17
K854236 HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS Nms Pharmaceuticals, Inc. IAF Class I 1986-10-10
K863503 HEMOLYSE Reagent Laboratory, Inc. GGK Class I 1986-10-03
K862047 COAGULATOR (8 CHANNEL) Med USA KQG Class II 1986-09-29
K863332 ATAC 4300 HEMATOLOGY CELL COUNTER Turpen Laboratory Systems, Inc. GKL Class II 1986-09-29
K863696 ARTHROSCOPIC SURGICAL POWER DEVICE American Edwards Laboratories KIT Class I 1986-09-29
K862156 ASSERACHROM D-DI KIT American Bioproducts Co. DAP Class II 1986-09-16
K862371 HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) Bio-Rad LCP Class II 1986-09-16
K860830 TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD Technicon Instruments Corp. LIZ Class II 1986-09-08
K863104 TOTAL HEMOGLOBIN J. D. Assoc. KHG Class II 1986-09-04
K863290 IL CELLECT 7 Instrumentation Laboratory CO GKL Class II 1986-09-04
K863084 COULTER COUNTER MODEL T-890 Coulter Electronics, Inc. GKL Class II 1986-09-04
K862774 ASSERACHROM PF4 KIT American Bioproducts Co. LCO Class II 1986-09-04
K863291 IL CELLECT 8 Instrumentation Laboratory CO GKL Class II 1986-09-04
K863085 COULTER COUNTER MODEL T-540 Coulter Electronics, Inc. GKL Class II 1986-09-04
K861973 D-DI TEST KIT American Bioproducts Co. GHH Class II 1986-09-04
K862374 CELLECT 8E AUTOMATED BLOOD CELL COUNTERS Instrumentation Laboratory CO GKL Class II 1986-09-04
K862301 IL SYSTEM 810, ACL AND THE REAGENT SETS Instrumentation Laboratory CO GJA Class II 1986-09-03
K862641 U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) U. S. Diagnostics, Inc. KHG Class II 1986-08-21
K862858 CBC-CAL (TM) PLUS/MULTIPLE R&D Systems, Inc. KRX Class II 1986-08-21
K861697 SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) Awareness Technology, Inc. LCP Class II 1986-08-19
K862202 VISION(TM) HEMOGLOBIN Abbott Laboratories KHG Class II 1986-08-18
K862556 SANDARE GLYCOHEMOGLOBIN PROCEDURE Sandare Chemical Co., Inc. LCP Class II 1986-08-08
K861780 COULTER COUNTER MODEL S PLUS JUNIOR Coulter Electronics, Inc. GKL Class II 1986-08-06
K861974 PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST Perceptive Systems, Inc. LNJ Class II 1986-08-04
K862302 BLOOD PLATELET ASSAY METHOD & APPARATUS Bellhouse Medical, Inc. JOZ Class II 1986-07-31
K862537 KOAGULAB* M COAGULATION SYSTEM Ortho Diagnostic Systems, Inc. JPA Class II 1986-07-21
K862318 FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR Fisher Scientific Co., LLC JPK Class II 1986-07-10
K862555 HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) Viromed Laboratories, Inc. KIR Class I 1986-07-10
K862089 V-MARC 88A COMPUTER V.Marc, A Div. of Pictorial, Inc. KQH Class II 1986-07-10
K851639 ANTI-LEU-12 B CELL REAGENT Bd Becton Dickinson Vacutainer Systems Preanalytic LJD Class II 1986-07-02
K862186 LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II Bio-Rad JPK Class II 1986-07-01
K861417 ASSERA-PLATE VWF KIT American Bioproducts Co. GGP Class II 1986-06-25
K861475 ASSERA-PLATE PROTEIN C KIT American Bioproducts Co. GGP Class II 1986-06-25
K861190 PTT AUTOMATE TEST KIT American Bioproducts Co. GGW Class II 1986-06-23
K861079 STACLOT PROTEIN C TEST KIT American Bioproducts Co. GGP Class II 1986-06-19
K862152 TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD Travenol Laboratories, S.A. KJA Class I 1986-06-16
K861996 DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-06-09
K854686 TE-25 COAGURO METER Future Impex Corp. JBP Class II 1986-06-04
K854687 ERMA HB-METER MODEL 303N Future Impex Corp. KHG Class II 1986-06-04
K861874 MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861887 MEM GLASGOW POWDERED MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861868 WILLIAMS MEDIUM E Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861869 GENTAMICIN-50MG/ML Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861873 MEM GLASGOW MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-05-29

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