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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
29
Latest Decision
1986-05-29

Clearances · page 29 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K861885 WILLIAMS MEDIUM E POWDER Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861049 HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA Sigma Chemical Co. GGP Class II 1986-05-29
K861870 DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861871 NCTC 109 MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861875 RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861867 MEM ALPHA EAGLE MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861048 PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765 Sigma Chemical Co. GGP Class II 1986-05-29
K861872 ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-05-29
K861886 DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM Hazleton Research Products, Inc. KIT Class I 1986-05-29
K860719 BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) Biotrack, Inc. JPA Class II 1986-05-23
K860721 BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST Biotrack, Inc. GJS Class II 1986-05-23
K861813 HUMAN AB SERUM - STERILE FILTERED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861217 VWF-IX:AG CONTROL PLASMA American Bioproducts Co. GGP Class II 1986-05-20
K861814 RHESUS MONKEY SERUM - STERILE FILTERED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861817 HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861809 LAMB SERUM - STERILE FILTERED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861810 CHICKEN SERUM - STERILE FILTERED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861815 BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861812 HUMAN SERUM - STERILE FILTERED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861811 MOUSE SERUM - STERILE FILTERED Hazleton Research Products, Inc. KIS Class I 1986-05-20
K861816 MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE Hazleton Research Products, Inc. KIS Class I 1986-05-20
K860572 GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET Pointe Scientific, Inc., LCP Class II 1986-05-16
K861216 PROTEIN C CONTROL PLASMA American Bioproducts Co. GGP Class II 1986-05-16
K861585 ULTRACLONE 01-2300 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1986-05-13
K860586 PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS Diagnostic Technology, Inc. GKL Class II 1986-05-07
K855237 BIOTEL (TM)/ KIDNEY American Diagnostic Corp. KHE Class II 1986-05-06
K861569 ULTRACLONE 01-700 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1986-05-05
K861159 SPECTRO VWF Ramco Laboratories, Inc. GGP Class II 1986-05-01
K860354 SEPRACELL LYMPHOCYTE SEPARATION MEDIUM Sepratech Corporation C/O Keller and Heckman JCF Class I 1986-04-18
K861373 HUMAN LUNG CARCINOMA CELLS (A549) Viromed Laboratories, Inc. KIR Class I 1986-04-18
K860899 DISPETTE II Ulster Scientific, Inc. JPH Class I 1986-04-14
K860812 SICKLE CELL REAGENT SET Michclone Associates, Inc. GHM Class II 1986-04-11
K861253 TISSUE CULTURE FLASK PL 732 PLASTIC Travenol Laboratories, S.A. KJA Class I 1986-04-11
K854358 EZ DETECH-URINE BLOOD TEST STICKS Self Care Systems, Inc. KHE Class II 1986-04-09
K860028 MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL Self Care Systems, Inc. KHE Class II 1986-04-07
K854685 DIGITAL-9 KEY LEUCOCYTE COUNTER Future Impex Corp. GKM Class I 1986-04-04
K860166 PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 Diagnostic Technology, Inc. GKL Class II 1986-04-04
K860371 ASSERACHROM VWF KIT American Bioproducts Co. GGP Class II 1986-04-04
K860122 HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME Medical Device Consultants, Inc. JBP Class II 1986-04-04
K860793 CAMCO STAIN PAK Cambridge Chemical Products, Inc. IAF Class I 1986-03-18
K860751 VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA Bio/Data Corp. JPK Class II 1986-03-18
K860783 MICRO CARRIER Tissue Culture Innovations KIT Class I 1986-03-12
K854166 HEMATOLOGY CALIBRATOR CONTROL Interscience Diagnostics, Inc. KRZ Class II 1986-03-12
K860786 RPMI 1640 HEPES Tissue Culture Innovations KIT Class I 1986-03-12
K860785 HAM'S F-12 W/NAHCO3 Tissue Culture Innovations KIT Class I 1986-03-12
K860787 DULBECCO'S MEM Tissue Culture Innovations KIT Class I 1986-03-12
K860795 SPOTTEST CALCOFLUOR WHITE REAGENT Difco Laboratories, Inc. LED Class I 1986-03-12
K860695 GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) Gibco Laboratories Life Technologies, Inc. KIW Class I 1986-03-12
K860784 DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 Tissue Culture Innovations KIP Class I 1986-03-12
K860788 HAM'S F-12 W/GLUTAMINE & NAHCO3 Tissue Culture Innovations KIT Class I 1986-03-12
K854938 COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. Diatech, Inc. JPA Class II 1986-03-12
K860762 GAMMA-FREE HORSE SERUM Flow Laboratories, Inc. KIS Class I 1986-03-10
K860752 GOAT SERUM (29-391-54) Flow Laboratories, Inc. KIS Class I 1986-03-10
K854015 FS TEST KIT American Bioproducts Co. JBN Class II 1986-03-06
K860342 MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP Bio/Data Corp. JPA Class II 1986-03-04
K854762 HEPANORM CALIBRATION PLASMA SET American Bioproducts Co. KFF Class II 1986-03-03
K854619 DETECTACULT Immunostics Co., Inc. KHE Class II 1986-03-03
K860623 CELLGRO HEPES BUFFER SOLUTION Mediatech, Inc. KIT Class I 1986-03-03
K860475 HEMOGLOBIN REAGENT SET Sterling Diagnostics, Inc. KHG Class II 1986-03-03
K855116 SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM Toa Medical Electronics USA, Inc. GKZ Class II 1986-02-24
K854677 ERMA PC-604 BLOOD CELL COUNTER Future Impex Corp. GKL Class II 1986-02-24
K860420 SICKLE CELL REAGENT SET Sterling Diagnostics, Inc. GHM Class II 1986-02-24
K854678 ERMA PC-602 PC-603 BLOOD CELL COUNTER Future Impex Corp. GKL Class II 1986-02-24
K855117 SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM Toa Medical Electronics USA, Inc. GKZ Class II 1986-02-24
K860317 NEUTROCOLOR Cytocolor, Inc. LED Class I 1986-02-20
K860320 GRANULOCOLOR Cytocolor, Inc. LED Class I 1986-02-20
K860319 MEGACOLOR Cytocolor, Inc. LED Class I 1986-02-20
K860321 LYSOCOLOR Cytocolor, Inc. LED Class I 1986-02-20
K860316 PANOPTIKON Cytocolor, Inc. LED Class I 1986-02-20
K854823 CBC-CAL/MULTIPLE R&D Systems, Inc. KSA Class II 1986-02-13
K860293 CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS Difco Laboratories, Inc. KIR Class I 1986-02-05
K853030 TECHNICON H*1 SYSTEM (HDW) Technicon Instruments Corp. GKL Class II 1986-02-05
K853027 TECHNICON H*1 SYSTEM (MPXI) Technicon Instruments Corp. GKZ Class II 1986-02-05
K860282 RPMI 1640 W/GLUTAMINE W/HEPES Newport Biosystems, Inc. KIT Class I 1986-02-05
K860292 CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000 Difco Laboratories, Inc. KIR Class I 1986-02-05
K854312 ASSERACHROM IX:AG American Bioproducts Co. GGP Class II 1986-02-04
K853029 TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA Technicon Instruments Corp. GKZ Class II 1986-01-24
K852988 TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. Technicon Instruments Corp. GKZ Class II 1986-01-21
K853722 PLT-4 PLATELET ANALYZER Texas Intl. Laboratories, Inc. GKL Class II 1986-01-17
K855085 TISSUE CULTURE MEDIA Newport Biosystems, Inc. KIT Class I 1986-01-13
K854546 MICROSAMPLE COAGULATION ANALYSER MODEL 110P Bio/Data Corp. JPA Class II 1986-01-07
K854089 DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT Diatech, Inc. JPA Class II 1986-01-06
K854090 DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT Diatech, Inc. JPA Class II 1986-01-06
K854014 ASSERA PLATE IX:AG KIT American Bioproducts Co. GGP Class II 1986-01-03
K854368 CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER Abbott Diagnostics GKZ Class II 1986-01-01
K854242 QBC CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1986-01-01
K854962 MICRO-MAT SYSTEM Ulster Scientific, Inc. GKJ Class I 1985-12-23
K854724 CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE Lifetrac, Inc. KIZ Class I 1985-12-13
K854567 PENICILLIN/STREPTOMYCIN SOLUTION Mediatech, Inc. KIT Class I 1985-12-06
K854377 HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc. JOX Class II 1985-12-04
K854376 HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc. JPA Class II 1985-12-04
K854353 PLATELET-TROL II R&D Systems, Inc. JPK Class II 1985-11-26
K853141 ACCESS DIGIWIPE SYSTEM Medtech Products, Inc. KHE Class II 1985-11-18
K853986 THROMBOPLASTIN-R REAGENT American Dade JPA Class II 1985-11-12
K853304 21 HEMATOLOGY REAGENTS In Vitro Diagnostics, Inc. GKZ Class II 1985-11-12
K854093 LEUCO PREP Bd Becton Dickinson Vacutainer Systems Preanalytic JCF Class I 1985-11-12
K853036 PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 Diagnostic Technology, Inc. GKL Class II 1985-11-05
K853239 HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY Haemachem, Inc. KFF Class II 1985-11-05
K854139 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB Eastman Kodak Company KHG Class II 1985-11-05
K853328 KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS Ortho Diagnostic Systems, Inc. JPA Class II 1985-11-05

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