meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
34
Latest Decision
1993-03-23

Clearances · page 19 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930376 ONE DRAM SHELL VIAL, CATALOG #02-211 Proteins Intl., Inc. KIR Class I 1993-03-23
K930378 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441 Proteins Intl., Inc. KIR Class I 1993-03-23
K930388 16 X 125 MM TEST TUBE, CATALOG #01-241 Proteins Intl., Inc. KIR Class I 1993-03-23
K930365 25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241 Proteins Intl., Inc. KIR Class I 1993-03-23
K925340 COAGULATION CONTROL CONTAINING HEMOGLOBIN Analytical Control Systems, Inc. JPA Class II 1993-03-23
K925604 ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT Ortho Diagnostic Systems, Inc. GJS Class II 1993-03-12
K924122 VARIANT BETA-THALASSEMIA SHORT PROGRAM Bio-Rad JPD Class II 1993-03-11
K922416 FIBRINOGEN RID TEST KIT The Binding Site, Ltd. KQJ Class II 1993-03-09
K925988 MULTIFIBREN Behring Diagnostics, Inc. KQJ Class II 1993-03-01
K922887 CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM Precision Biologicals, Inc. GGN Class II 1993-02-25
K926222 OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 Helena Laboratories JPA Class II 1993-02-12
K920767 NYCOPLASTIN Nycomed Pharma AS GJS Class II 1993-02-12
K923773 CELLEXIS HEMATOLOGY ANALYZER Technalysis, Inc. GKZ Class II 1993-02-05
K925863 SPUNCRIT bioMerieux, Inc. GKG Class II 1993-02-05
K922744 CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 Coulter Immunology GKZ Class II 1993-02-05
K925528 BIOVATION K-MANAGER Biovation, Inc. GKZ Class II 1993-02-05
K922745 CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 Coulter Immunology GKZ Class II 1993-02-05
K925492 BIOMERIEUX HEMOLAB THROMBOMAT Biomerieux Vitek, Inc. GJS Class II 1993-02-03
K924637 HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT International Technidyne Corp. GFO Class II 1993-01-27
K923761 ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM International Technidyne Corp. JPA Class II 1993-01-21
K925344 COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA Coulter Corp. GKZ Class II 1993-01-21
K924813 VARIANT SICKLE CELL SHORT PROGRAM Bio-Rad GKA Class II 1993-01-14
K924638 HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT International Technidyne Corp. GFO Class II 1993-01-14
K924884 IL TEST(TM) PRO-CHROM Instrumentation Laboratory CO GGP Class II 1993-01-14
K925204 BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED Beckman Instruments, Inc. LCP Class II 1993-01-12
K925452 DADE HEPZYME Baxter Diagnostics, Inc. JBR Class II 1993-01-11
K924926 MSI-HCT Medical Specialties, Inc. GLK Class II 1993-01-07
K921279 CD4 CYTOSPHERES KIT Coulter Electronics, Inc. GKZ Class II 1992-12-29
K923731 STACLOT LA TEST KIT American Bioproducts Co. GFO Class II 1992-12-23
K924509 CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION Behring Diagnostics, Inc. JPA Class II 1992-12-21
K924453 MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) Organon Teknika Corp. JPA Class II 1992-12-18
K911731 LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR Bd Becton Dickinson Vacutainer Systems Preanalytic JCF Class I 1992-12-15
K922201 COAMATE PROTEIN C CHROMOGENIC ASSAY Chromogenix AB GGP Class II 1992-12-07
K924619 CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101 Proteins Intl., Inc. KIR Class I 1992-12-07
K924595 CYTOQUANT HNFS CELLS Proteins Intl., Inc. KIR Class I 1992-12-07
K922565 NEOPLASTINE(R) CI KIT American Bioproducts Co. GJS Class II 1992-12-07
K924616 CYTOQUANT HEP-2 CELLS, CATALOG #02-251 Proteins Intl., Inc. KIR Class I 1992-12-07
K924617 CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251 Proteins Intl., Inc. KIR Class I 1992-12-07
K924614 CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS Proteins Intl., Inc. KIR Class I 1992-12-07
K924620 CYTOQUANT MRC-5 CELLS, CATALOG #03-101 Proteins Intl., Inc. KIR Class I 1992-12-07
K924623 CYTOQUANT A-549 CELLS, CATALOG #03-201 Proteins Intl., Inc. KIR Class I 1992-12-07
K924615 CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK Proteins Intl., Inc. KIR Class I 1992-12-07
K924624 CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201 Proteins Intl., Inc. KIR Class I 1992-12-07
K924622 CYTOQUANT A-549 CELLS, CATALOG #02-201 Proteins Intl., Inc. KIR Class I 1992-12-07
K924618 CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251 Proteins Intl., Inc. KIR Class I 1992-12-07
K924612 CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301 Proteins Intl., Inc. KIR Class I 1992-12-07
K924625 CYTOQUANT HLNFS CELLS, CATLOG #03-151 Proteins Intl., Inc. KIR Class I 1992-12-07
K924613 CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301 Proteins Intl., Inc. KIR Class I 1992-12-07
K924621 CYTOQUANT MRC-5 CELLS, CATALOG #02-101 Proteins Intl., Inc. KIR Class I 1992-12-07
K924173 HEMOCARD(TM) CONTROL Isolab, Inc. JCM Class II 1992-12-01
K924405 CONTROL PLASMA P Behring Diagnostics, Inc. GGC Class II 1992-12-01
K924124 BEHRING FIBRINTIMER A Behring Diagnostics, Inc. JPA Class II 1992-12-01
K924394 CLOTTING FACTOR V DEFICIENT PLASMA Behring Diagnostics, Inc. GJT Class II 1992-12-01
K924404 CLIBRATION PLASMAS Behring Diagnostics, Inc. GGN Class II 1992-12-01
K921681 CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL Isolab, Inc. GGM Class II 1992-11-17
K924393 STANDARD HUMAN PLASMA Behring Diagnostics, Inc. JPA Class II 1992-11-16
K923971 QC-CHEX Streck Laboratories, Inc. JPK Class II 1992-11-16
K924496 GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT Drew Scientific , Ltd. JPD Class II 1992-11-16
K922934 ENZYGNOST F 1+2 Behring Diagnostics, Inc. MIF Class II 1992-11-16
K922174 COAG-CONTROL [N] KIT American Bioproducts Co. GGN Class II 1992-10-26
K923921 IL TEST PT FIBRINOGEN HS Instrumentation Laboratory CO GIS Class II 1992-10-26
K921396 PLATELIN L Organon Teknika Corp. GFO Class II 1992-10-19
K920668 MINUTEX D-DIMER LATEX TEST Biopool AB GHH Class II 1992-10-16
K923530 COULTER MULTI-Q-PREP Coulter Electronics, Inc. GKH Class I 1992-10-14
K922782 SPECTROLYSE/PL PAI KIT Biopool AB GGP Class II 1992-10-09
K921798 PROPPER SUPER SERACULT(R) Propper Mfg. Co., Inc. KHE Class II 1992-10-05
K923220 THROMBIN CLOT TIME TEST PROCEDURE Medical Laboratory Automation Systems, Inc. GJA Class II 1992-09-29
K921831 IMX(R) GLYCATED HEMOGLOBIN Abbott Laboratories LCP Class II 1992-09-29
K921449 NEW STACHROM ANTIPLASMIN American Bioproducts Co. GGP Class II 1992-09-23
K923593 HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS International Technidyne Corp. KQJ Class II 1992-09-22
K923121 QBC HEMACAN HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1992-09-22
K923594 CLOTTRAC COAGULATION CONTROL Medtronic Hemotec, Inc. JBP Class II 1992-09-21
K923237 TECHNICON H*2 Heraeus Kulzer, Inc. GKZ Class II 1992-09-11
K914188 KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM Ortho Diagnostic Systems, Inc. JPA Class II 1992-08-26
K922800 PLATELET AGGREGATION REAGENTS Chrono-Log Corp. GHR Class II 1992-08-26
K923318 COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL Helena Laboratories JPD Class II 1992-08-25
K923317 COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL Helena Laboratories JPD Class II 1992-08-25
K921223 ACS FREEZE-DRIED APTT REAGENT Analytical Control Systems, Inc. GFO Class II 1992-08-18
K920820 MODIFICATION COLUMNMATE Helena Laboratories LCP Class II 1992-08-17
K922181 COULTER MH009 Coulter Electronics, Inc. GKZ Class II 1992-08-17
K920012 IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM Instrumentation Laboratory CO GGP Class II 1992-08-12
K915698 FIBRINOSTIKA TDP MICROELISA SYSTEM Organon Teknika Corp. DAP Class II 1992-08-05
K920397 REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT Medical Analysis Systems, Inc. LCP Class II 1992-08-04
K921118 ACS APCT REAGENT Analytical Control Systems, Inc. GFO Class II 1992-07-28
K922084 MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM Gen Trak, Inc. GKZ Class II 1992-07-28
K922085 MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM Gen Trak, Inc. GKZ Class II 1992-07-28
K920449 POINTE 750 GLYCOMETER Pointe Scientific, Inc., LCP Class II 1992-07-28
K921326 DADE RECOMBOPLASTIN S Baxter Diagnostics, Inc. GJS Class II 1992-07-27
K922704 COULTER MAXM W/ AUTOLOADER Coulter Electronics, Inc. GKZ Class II 1992-07-27
K921495 DIA STRIPS SYSTEM, MODIFIED Symcon Intl., Inc. JIO Class II 1992-07-21
K922031 HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL Medtronic Hemotec, Inc. JOX Class II 1992-07-21
K920198 GLYCOMAT HAEMOGLOBIN ANALYSER Drew Scientific , Ltd. LCP Class II 1992-07-21
K920943 FDP PLASMA TEST KIT American Bioproducts Co. DAP Class II 1992-07-13
K921676 COLUMNMATE II Helena Laboratories LCP Class II 1992-07-10
K921567 COULTER MH017 Coulter Electronics, Inc. GKZ Class II 1992-07-06
K921465 CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) Helena Laboratories GKP Class II 1992-06-29
K920719 IVOS ANALYZER Hamilton Thorne Research GKL Class II 1992-06-29
K920258 QBC FIBRINOGEN Bd Becton Dickinson Vacutainer Systems Preanalytic KQJ Class II 1992-06-26
K922040 NEOPLASTINE CI PLUS American Bioproducts Co. GJS Class II 1992-06-23
K914847 CD8 MONOCLONAL ANTIBODIES Gen Trak, Inc. LIZ Class II 1992-06-19

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