meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
30
Latest Decision
1995-09-26

Clearances · page 16 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943519 HBPM/LMWH CONTROL KIT American Bioproducts Co. KFF Class II 1995-09-26
K945205 QBC ACCUTUBE Becton Dickinson Diagnostic Instrument Systems GKZ Class II 1995-09-25
K941752 SPECTROLYSE ANTIPLASMIN KIT Biopool AB GGP Class II 1995-09-25
K952338 STA-COAG CONTROL [P] PLUS KIT American Bioproducts Co. GGC Class II 1995-09-21
K952720 AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II Aalto Scientific, Ltd. JPK Class II 1995-09-20
K945678 DATACELL 18MS Danam Electronics GKZ Class II 1995-09-12
K952252 ADP REAGENT, MODIFIED Helena Laboratories GHR Class II 1995-09-08
K953498 OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL Immunotech, Inc. GKZ Class II 1995-09-08
K952560 SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER Sienco, Inc. JPA Class II 1995-09-05
K952245 SF-CHECK Streck Laboratories, Inc. JPK Class II 1995-09-01
K951497 CASCASE 480 SNSLYZER Helena Laboratories JPA Class II 1995-09-01
K943515 ROTACHROM HEPARIN TEST KIT American Bioproducts Co. KFF Class II 1995-08-31
K943516 ROTACHROM HBPM/LMWH TEST KIT American Bioproducts Co. KFF Class II 1995-08-31
K950742 CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT Coulter Corp. GKZ Class II 1995-08-25
K946193 FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 More Diagnostics GIL Class II 1995-08-24
K946265 FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 Clinical Controls, Inc. GIL Class II 1995-08-24
K950057 TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems GKZ Class II 1995-08-22
K952789 OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES Immunotech Corp. GKZ Class II 1995-08-14
K945940 COATEST(R) APC(TM) RESISTANCE Axis-Shield Doc AS GGW Class II 1995-08-07
K951071 ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS Alko Diagnostic Corp. KRZ Class II 1995-07-24
K950949 COULTER MH025A Coulter Corp. GKZ Class II 1995-07-20
K942087 BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES Biopool AB GGP Class II 1995-07-13
K946274 COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN Helena Laboratories LCP Class II 1995-07-11
K952182 OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES Immunotech, Inc. GKZ Class II 1995-07-05
K933934 GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A Sigma Diagnostics, Inc. JBF Class II 1995-06-29
K944126 CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES Caltag Laboratories, Inc. GKZ Class II 1995-06-20
K944127 CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY Caltag Laboratories, Inc. GKZ Class II 1995-06-20
K944128 CALTAG CD4 R-PE MONOCLONAL ANTIBODY Caltag Laboratories, Inc. GKZ Class II 1995-06-20
K943571 MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS More Diagnostics DAP Class II 1995-06-15
K945837 SYSMEX(TM) F-820, 520 Sysmex Corp. GKZ Class II 1995-06-09
K936285 ABBOTT VISION GLYCATED HB, MODIFICATION Abbott Laboratories LCP Class II 1995-06-09
K925433 THE STACHROM HEPARIN ASSAY KIT American Bioproducts Co. KFF Class II 1995-05-23
K942050 HEMOLAB COFAC IX Biomerieux Vitek, Inc. GJT Class II 1995-05-19
K942049 BIOMERIEUX HEMOLAB COFAC II Biomerieux Vitek, Inc. GJT Class II 1995-05-19
K925255 TRAX(TM) CD4 TEST KIT T Cell Diagnostics, Inc. GKZ Class II 1995-05-15
K943517 STACLOT HEPARIN TEST KIT American Bioproducts Co. KFF Class II 1995-05-11
K940209 ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL Ortho Diagnostic Systems, Inc. GGN Class II 1995-05-11
K942884 COAGUCHEK SYSTEM Boehringer Mannheim Corp. GJS Class II 1995-05-11
K943283 HEPARIN MANAGEMENT TEST CARD; HMT CARD Cardiovascular Diagnostics, Inc. KFF Class II 1995-05-10
K942820 H292 Bartels, Inc. KIR Class I 1995-05-05
K951361 DCA 2000 SYSTEM FOR HEMOGLOBIN A1C Heraeus Kulzer, Inc. LCP Class II 1995-05-05
K950626 OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES Immunotech Corp. GKZ Class II 1995-05-05
K935598 PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 Clinical Controls, Inc. GIL Class II 1995-05-02
K945078 HEMOCHRON HNPT/FACTOR VI PT+ International Technidyne Corp. GJS Class II 1995-04-28
K932531 ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE Ortho Diagnostic Systems, Inc. GKZ Class II 1995-04-26
K941713 ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1995-04-26
K932532 ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1995-04-26
K935748 ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT Ortho Diagnostic Systems, Inc. GJS Class II 1995-04-26
K932530 ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1995-04-26
K941965 EZ-RANGE Hematronix, Inc. JPK Class II 1995-04-25
K926551 BEHRING FIBRINTIMER A Behring Diagnostics, Inc. JPA Class II 1995-04-18
K951012 N/T PROTEIN CONTROL PY Behring Diagnostics, Inc. GIL Class II 1995-04-17
K941616 VARIANT TOTAL GHB PROGRAM Bio-Rad LCP Class II 1995-04-14
K944279 AT-III CALIBRATOR American Bioproducts Co. JBQ Class II 1995-04-07
K936056 HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES Dipro Diagnostic Products GmbH KHE Class II 1995-04-05
K940490 DV TEST AND DVV CONFIRM American Diagnostica, Inc. GIR Class I 1995-04-05
K942096 TOA MEDICAL ELECTRONICS CA-1000 Sysmex Corp. JPA Class II 1995-03-24
K944115 HEPARIN ASSAY CARTRIDGES AND CONTROLS Medtronic Hemotec, Inc. GFT Class II 1995-03-24
K943153 MICROSAMPLE COAGULATION ANALYZER Bio/Data Corp. GKP Class II 1995-03-24
K942097 TOA MEDICAL ELECTRONICS CA-5000 Sysmex Corp. JPA Class II 1995-03-24
K941210 PTT-LT TEST KIT American Bioproducts Co. GGW Class II 1995-03-21
K943518 STA SYSTEM CONTROL [N] + [P] KIT American Bioproducts Co. GGN Class II 1995-03-21
K944691 ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II International Technidyne Corp. GGN Class II 1995-03-15
K950942 CRIT-LINE HEMATOCRIT ALERT In-Line Diagnostics Corp. JPI Class II 1995-03-14
K943967 ONYX Coulter Corp. GKZ Class II 1995-03-06
K950015 HUMAN PROTEIN C RID TEST KIT Jay H. Geller GGP Class II 1995-03-06
K940240 IKAROS Metasystems GmbH LNJ Class II 1995-02-24
K940082 THROMBOSCREEN THROMBOPLASTIN-DS Pacific Hemostasis GJS Class II 1995-02-14
K940430 SEDRATROL Medical Specialties Intl., Inc. GJR Class II 1995-02-06
K944227 ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER Medical Laboratory Automation Systems, Inc. GKP Class II 1995-02-03
K943894 SYSMEX K-4500 Sysmex Corp. GKZ Class II 1995-02-03
K942117 STA AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. GKP Class II 1995-02-01
K945692 MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) Dako Corp. GKZ Class II 1995-01-25
K924425 PROTEIN C REAGENT, COAGULOMETRIC Behring Diagnostics, Inc. GGP Class II 1995-01-24
K942222 QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS Isolab, Inc. JCM Class II 1995-01-20
K942276 QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY Isolab, Inc. GIQ Class II 1995-01-20
K935851 BIOMERIEUX HEMOLAB COFAC X Biomerieux Vitek, Inc. GJT Class II 1995-01-17
K935850 BIOMERIEUX HEMOLAB COFAC VII Biomerieux Vitek, Inc. GJT Class II 1995-01-17
K945414 RISTOCETIN COFACTOR ASSAY KIT Chrono-Log Corp. GGP Class II 1995-01-11
K934210 HEMOLAB PROTEIN C CHROMOGENIC ASSAY Biomerieux Vitek, Inc. GGP Class II 1994-12-22
K931992 HEMOLAB Biomerieux Vitek, Inc. GKP Class II 1994-12-22
K934156 BIOMERIEUX HEMOLAB AT III Biomerieux Vitek, Inc. JBQ Class II 1994-12-22
K943268 SCS-1000 (SYSMEX CALIBRATOR SYSTEM) Streck Laboratories, Inc. KSA Class II 1994-12-15
K941171 TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Miles, Inc. GKZ Class II 1994-12-14
K943336 RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1994-12-12
K943335 RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1994-12-12
K944751 COULTER FLOW SET Coulter Corp. JPK Class II 1994-12-08
K935169 APTT-ES Helena Laboratories GFO Class II 1994-12-02
K943889 VERO CELL CULTURE Neogenex KIR Class I 1994-11-28
K943891 RD CULTURE CELL Neogenex KIR Class I 1994-11-28
K943888 MDCK CELL CULTURE Neogenex KIR Class I 1994-11-28
K943890 WI38 CELL CULTURE Neogenex KIR Class I 1994-11-28
K943887 HUMAN NEWBORN FORESKIN CELL CULTURE Neogenex KIR Class I 1994-11-28
K943886 BGM CELL CULTURE Neogenex KIR Class I 1994-11-28
K943884 PRIMARY MONKEY KIDNEY CELL CULTURE Neogenex KIR Class I 1994-11-28
K943885 PRIMARY RABBIT KIDNEY CELL CULTURE Neogenex KIR Class I 1994-11-28
K935307 DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA Baxter Diagnostics, Inc. DDQ Class II 1994-11-22
K935702 DADE INNOVIN II Baxter Diagnostics, Inc. GJS Class II 1994-11-22
K943284 MONOCLONAL MOUSE ANTI-HUMAN B-CELL Dako Corp. GKZ Class II 1994-11-21
K944253 MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 Dako Corp. GKZ Class II 1994-11-21

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