meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
39
Latest Decision
2003-07-03

Clearances · page 9 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K024337 GENERAL SEMEN ANALYSIS (GSA) KIT Bioshaf , Ltd. POV Class II 2003-07-03
K031478 MICROHEATER Belmont Instrument Corp. BSB Class II 2003-07-02
K030687 K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C Kamiya Biomedical Co. DAP Class II 2003-06-27
K023335 QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) Qc Sciences, LLC NJW Class II 2003-06-18
K030965 CONTROL PLASMA LMW HEPARIN Instrumentation Laboratory CO GGN Class II 2003-06-06
K030845 COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING Roche Diagnostics Corp. GJS Class II 2003-05-22
K030828 TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) Beckman Coulter, Inc. GKZ Class II 2003-05-21
K031122 HEMOSIL FACTOR X DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2003-05-19
K030513 CELL-DYN 1800 SYSTEM Abbott Laboratories GKZ Class II 2003-05-12
K023654 GLYCA-DIRECT FRUCTOSAMINE Polymedco, Inc. LCP Class II 2003-05-02
K023991 CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 Precision Biologic JBQ Class II 2003-04-28
K030606 COULTER LH 750 BODY FLUIDS APPLICATION Beckman Coulter, Inc. GKZ Class II 2003-04-21
K030291 COULTER ACT 5DIFF AUTOLOADER (AL) Beckman Coulter, Inc. GKZ Class II 2003-04-17
K030799 MICROS 60 Abx Diagnostics GKZ Class II 2003-04-08
K030216 COLONCARE Care Products, Inc. KHE Class II 2003-04-02
K030818 HEMOCHRON RESPONSE/SYSTEM International Technidyne Corp. JPA Class II 2003-04-02
K030740 MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp. GHH Class II 2003-04-01
K024006 G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE Pointe Scientific, Inc., JBF Class II 2003-03-31
K023990 CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 Precision Biologic GGP Class II 2003-03-19
K030287 HEMOSIL FACTOR XI DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2003-03-19
K023297 URS-1B (BLOOD TEST) Teco Diagnostics JIO Class II 2003-03-06
K030408 CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A Beckman Coulter, Inc. GKZ Class II 2003-03-04
K030182 LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 Bio-Rad GGN Class II 2003-02-24
K023761 PLATELETWORKS, MODELS PW-A, PW-C Helena Laboratories JOZ Class II 2003-02-14
K024082 HEMOSIL FACTOR VII DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2003-02-12
K030144 MODIFICATION TO PENTRA 60 AND PENTRA 60C+ Abx Diagnostics GKZ Class II 2003-01-31
K023561 ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM International Technidyne Corp. GKR Class II 2003-01-31
K023141 MODIFICATION TO STANDARD HUMAN PLASMA Dade Behring, Inc. JPA Class II 2003-01-16
K022976 STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D Dade Behring, Inc. DAP Class II 2003-01-16
K024173 CDS 3-PD HEMATOLOGY CONTROLS Clinical Diagnostic Solutions, Inc. JPK Class II 2003-01-14
K023839 HEMOSIL FACTOR V DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2003-01-14
K023763 RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS Randox Laboratories, Ltd. LCP Class II 2003-01-13
K024002 PENTRA 80 Abx Diagnostics GKZ Class II 2003-01-03
K023656 SICKLE-CHEX SOLUBILITY KIT Streck Laboratories, Inc. GHM Class II 2002-12-30
K022661 A1CNOW FOR HOME USE Metrika, Inc. LCP Class II 2002-12-13
K023362 FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN Fisher Diagnostics GKP Class II 2002-12-09
K023046 SST SALIVA SUPPORTING TABLETS Sinclair Pharmaceuticals, Ltd. LED Class I 2002-12-02
K022977 STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C Dade Behring, Inc. DAP Class II 2002-11-27
K021897 RANDOX HAEMOGLOBIN A1C Randox Laboratories, Ltd. LCP Class II 2002-11-26
K022021 VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT Vital Scientific N.V. GFO Class II 2002-11-01
K023312 CONTROL PLASMA P Dade Behring, Inc. GGC Class II 2002-11-01
K023309 CONTROL PLASMA N Dade Behring, Inc. GIZ Class II 2002-11-01
K021976 FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON Vital Scientific N.V. KQG Class II 2002-10-25
K021190 PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 Roche Diagnostics Corp. GJS Class II 2002-10-25
K020831 PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 Roche Diagnostics Corp. GJS Class II 2002-10-24
K021923 INRATIO SELF-TEST Hemosense, Inc. GJS Class II 2002-10-24
K022774 IQ 200 SYSTEM Intl. Remote Imaging Systems LKM Class II 2002-10-21
K022668 ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD Bayer Diagnostics Corp. GKZ Class II 2002-10-15
K023032 LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL Bioresource Technology, Inc. GFS Class II 2002-10-08
K020810 VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 bioMerieux, Inc. DAP Class II 2002-10-03
K012138 MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) Chroma Vision Medical Systems, Inc. MYA Class II 2002-09-30
K022922 HARMONY INR MONITORING SYSTEM Lifescan, Inc. GJS Class II 2002-09-30
K022512 CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 Immunicon Corp. GKH Class I 2002-09-30
K022755 LIFEGUARD Medtek, LLC KHE Class II 2002-09-24
K022968 ADVIA TESTPOINT CSF CONTROL Bayer Diagnostics Corp. JPK Class II 2002-09-24
K021746 SQA V, SPERM QUALITY ANALYZER Medical Electronic Systems, LLC POV Class II 2002-09-20
K022331 ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD Bayer Diagnostics Corp. GKL Class II 2002-09-11
K022528 IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ Iq Corp. GKZ Class II 2002-09-11
K021162 AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED Sigma Diagnostics, Inc. JPA Class II 2002-08-30
K022290 PROTEIN S AC Dade Behring, Inc. GGP Class II 2002-08-27
K022550 COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS Instrumentation Laboratory CO JBQ Class II 2002-08-27
K013305 ENOXAPARIN TEST CARD Cardiovascular Diagnostics, Inc. KFF Class II 2002-08-23
K020710 BIOTEST HEMOGLOBIN MEASURING SYSTEM Biotest Medizintechnik GmbH GKR Class II 2002-08-14
K022195 COAMATIC AT-400 Instrumentation Laboratory CO JBQ Class II 2002-08-07
K021877 MDA D-DIMER bioMerieux, Inc. GHH Class II 2002-08-07
K022161 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc. GKZ Class II 2002-07-29
K022200 PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 Abx Diagnostics GKZ Class II 2002-07-29
K022046 VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL Vital Scientific N.V. GGN Class II 2002-07-23
K020616 BAYER RAPIDPOINT 405 SYSTEM Bayer Diagnostics Corp. GKR Class II 2002-07-17
K020979 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 Dade Behring, Inc. GKP Class II 2002-06-27
K021922 MODIFICATION TO PARA 5X Streck Laboratories, Inc. JPK Class II 2002-06-25
K021241 SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I Sysmex Corporation of America GKZ Class II 2002-06-25
K021924 MEDICA EASYQC HEMATOCRIT CONTROL Bionostics, Inc. GLK Class II 2002-06-24
K021423 INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST Alfa Scientific Designs, Inc. KHE Class II 2002-06-17
K021484 HEMOGLOBIN A1C CONTROL Canterbury Scientific , Ltd. LCP Class II 2002-06-14
K020753 DEROYAL SURGICAL, UMBILICUP Deroyal KSR Class II 2002-06-13
K012701 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) Accumetrics, Inc. JOZ Class II 2002-06-12
K021150 COULTER CELLPREP Beckman Coulter, Inc. GKH Class I 2002-06-11
K020914 ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 Helena Laboratories JBP Class II 2002-05-23
K013596 MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) Accumetrics, Inc. JOZ Class II 2002-05-16
K021024 HEMOSIL HIGH ABNORMAL CONTROL ASSAYED Instrumentation Laboratory CO GGN Class II 2002-05-16
K020840 VITAL SCIENTIFIC PT WITH CALCIUM Vital Scientific N.V. GJS Class II 2002-05-15
K021023 HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) Instrumentation Laboratory CO GGN Class II 2002-05-14
K020489 G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE Tosoh Medics, Inc. JPD Class II 2002-05-14
K020618 AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL Aalto Scientific, Ltd. GLK Class II 2002-05-14
K020355 I-STAT PROTHROMBIN TIME TEST I-Stat Corporation GJS Class II 2002-05-14
K021022 HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) Instrumentation Laboratory CO GGN Class II 2002-05-14
K020679 INRATIO Hemosense, Inc. GJS Class II 2002-05-06
K020532 POLYMEDCO HBA1C TEST Polymedco, Inc. LCP Class II 2002-04-24
K013637 ACTICHROME HEPARIN (ANTI-FIIA) American Diagnostica, Inc. KFF Class II 2002-04-16
K020878 LYPHOCHEK HEMOSTASIS, MODELS 798, 799 Bio-Rad GGC Class II 2002-04-15
K020496 HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY Sysmex Corporation of America GKZ Class II 2002-04-12
K020469 CAL-CHEX CD PLUS Streck Laboratories, Inc. KRX Class II 2002-04-04
K013169 IMMUNE CELL FUNCTION ASSAY Cylex, Inc. NID Class II 2002-04-02
K020798 HEMOCHRON JR. SIGNATURE + International Technidyne Corp. JPA Class II 2002-03-28
K012755 AUTODIMER ASSAY MODEL # 1431 Xtrana, Inc. DAP Class II 2002-03-15
K013492 IMUBIND TPA ELISA, MODEL 860 American Diagnostica, Inc. GGP Class II 2002-03-13
K012805 AUTOMARQER Hamilton Thorne Research POV Class II 2002-03-13
K012960 BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR Biogenex Laboratories MXZ Class II 2002-03-08
K013318 ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 American Diagnostica, Inc. KFF Class II 2002-03-08

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