meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
31
Latest Decision
1985-05-08

Clearances · page 31 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850412 GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY Warner-Lambert Co. JBQ Class II 1985-05-08
K850409 GEN. DIAG. CHROMOSTRATE REF. PLASMA Warner-Lambert Co. JPA Class II 1985-05-08
K850411 GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY Warner-Lambert Co. LGP Class II 1985-05-08
K850486 GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY Warner-Lambert Co. KFF Class II 1985-05-08
K850386 SYSTEM 8000 CELL COUNTER Baker Instructions Corp. GKL Class II 1985-05-02
K851481 SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR Difco Laboratories, Inc. LED Class I 1985-04-29
K851493 KINYOUN ACID FAST STAIN KIT Accra Laboratories, Inc. JTS Class I 1985-04-29
K851494 TWO-STEP ACID FAST BACTERIA STAIN Accra Laboratories, Inc. JTS Class I 1985-04-29
K850886 COMPRESSION HIP SCREW SYSTEM Pfizer, Inc. KIT Class I 1985-04-19
K850990 HFF GENCELLS Bioassay Systems Research Corp. KIT Class I 1985-04-12
K843062 TBM-REAGENT FOR T,B CELL & MONOCYTES Bd Becton Dickinson Vacutainer Systems Preanalytic LIZ Class II 1985-04-03
K842277 DIMERTEST LATEX Mabco, Inc. GHH Class II 1985-04-03
K850239 SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- Toa Medical Electronics USA, Inc. GIF Class I 1985-04-01
K844910 SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - Toa Medical Electronics USA, Inc. GKZ Class II 1985-04-01
K850250 TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH Technicon Instruments Corp. JPK Class II 1985-04-01
K850094 LASER-GLOBIN POWDER Hematology Marketing Assoc. GKR Class II 1985-03-29
K850096 LASER-GLOBIN Hematology Marketing Assoc. GKR Class II 1985-03-29
K850944 NSI LYSING-D REAGENT -4000 ML Nobel Scientific Industries, Inc. GGK Class I 1985-03-29
K850095 LASER-DIL Hematology Marketing Assoc. GIF Class I 1985-03-29
K850097 LASER-LYSE Hematology Marketing Assoc. GGK Class I 1985-03-29
K850679 TRYPSIN-EDTA SOLUTION Hazleton Research Products, Inc. KIT Class I 1985-03-29
K845019 CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER Abbott Diagnostics GKL Class II 1985-03-26
K845000 THROMBINEX BOVINE THROMBIN Bio/Data Corp. GJA Class II 1985-03-26
K850891 DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT Sigma Chemical Co. KIT Class I 1985-03-25
K850806 CORNING BLOOD COLLECTION CAPILLARY TUBES Corning Medical & Scientific GIO Class I 1985-03-25
K850922 MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL Sigma Chemical Co. KIT Class I 1985-03-25
K850890 MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED & Sigma Chemical Co. KIT Class I 1985-03-25
K850921 MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE - Sigma Chemical Co. KIT Class I 1985-03-25
K844927 QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS Bhp Diagnostix, Inc. JPK Class II 1985-03-22
K844928 QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE Bhp Diagnostix, Inc. JPK Class II 1985-03-22
K844897 HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 Medical Specialties Laboratories JPK Class II 1985-03-22
K850680 ENCORE FERRITIN REAGENT Hybritech, Inc. JMB Class II 1985-03-21
K850537 CELL CULTURE REFEED MEDIUM Hillcrest Biologicals KIT Class I 1985-03-20
K850227 HAM'S MIXTURE F-12 MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-11
K850232 E.MEM POWDERED MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850233 MEM ESSENTIAL AMINO ACIDS 50X Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850220 ALPHA MEM W/O NUCLEOSIDES POWDER MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850226 MCCOY'S MEDIUM 5A, IWAKATA & GRACE MODIFICA- Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850228 HAM'S MIXTURE F-10 MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850234 H-MEM POWDERED MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850217 CYNOMOLGUS MONKEY BLOOD IN ALSEVER'S Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850237 EBSS W/O CA & MG Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850225 FISCHER'S MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850219 MEM W/SPINNER SALTS POWDER MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850218 SWIM'S S-77 POWDER MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850236 BME AMINO ACIDS 100X Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850235 BME VITAMINS 100X Hazleton Research Products, Inc. KIT Class I 1985-03-07
K850223 EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED Hazleton Research Products, Inc. KIT Class I 1985-03-07
K842668 LIQUI-HEME HEMOGLOBIN CALIBRATORS Biodiagnostic Intl KRZ Class II 1985-03-05
K844708 TRI-COUNT CALIBRATOR Hematology Marketing Assoc. KSA Class II 1985-03-05
K850229 RPMI-1603 MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-05
K844782 NSI ELT-D DILUTING FLUID 4000ML Nobel Scientific Industries, Inc. GIF Class I 1985-03-05
K844645 QBC CENTRIFUGAL HEMATOLOGY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1985-03-05
K850224 WAYMOUTH'S MEDIUM MB 752/1 Hazleton Research Products, Inc. KIT Class I 1985-03-05
K850230 RPMI-1634 MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-05
K850222 HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED- Hazleton Research Products, Inc. KIT Class I 1985-03-05
K850221 ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM Hazleton Research Products, Inc. KIT Class I 1985-03-05
K850510 EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN Mediatech, Inc. KIT Class I 1985-03-04
K850542 SURGICUTT - BLEEDING TIME DEVICE International Technidyne Corp. JCA Class II 1985-03-01
K850514 ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID Mediatech, Inc. KIT Class I 1985-02-27
K850522 MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS Mediatech, Inc. KIT Class I 1985-02-27
K850521 MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS Mediatech, Inc. KIT Class I 1985-02-27
K850525 DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE Mediatech, Inc. KIT Class I 1985-02-27
K850517 MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS Mediatech, Inc. KIT Class I 1985-02-27
K850089 MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT Sigma Chemical Co. KIT Class I 1985-02-27
K850524 HBSS-HANKS' BALANCED SALT SOLUTION Mediatech, Inc. KIT Class I 1985-02-27
K850518 NA PYRUVATE-SODIUM PYRUVATE Mediatech, Inc. KIT Class I 1985-02-27
K845014 MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES Sigma Chemical Co. KIT Class I 1985-02-27
K850511 EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA Mediatech, Inc. KIT Class I 1985-02-27
K850513 RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 Mediatech, Inc. KIT Class I 1985-02-27
K850092 DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A Sigma Chemical Co. KIT Class I 1985-02-27
K850512 DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM Mediatech, Inc. KIT Class I 1985-02-27
K850523 EBSS-EARLE'S BALANCE SALT SOLUTION Mediatech, Inc. KIT Class I 1985-02-27
K850526 EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION Mediatech, Inc. KIT Class I 1985-02-27
K845013 RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO Sigma Chemical Co. KIT Class I 1985-02-27
K845012 NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE Sigma Chemical Co. KIT Class I 1985-02-27
K850091 BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE Sigma Chemical Co. KIT Class I 1985-02-27
K850520 NEAA-NON-ESSENTIAL AMINO ACIDS Mediatech, Inc. KIT Class I 1985-02-27
K850515 HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM Mediatech, Inc. KIT Class I 1985-02-27
K850519 GLUTAMINE-1-GLUTAMINE Mediatech, Inc. KIT Class I 1985-02-27
K850090 DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/1000 MG/L Sigma Chemical Co. KIT Class I 1985-02-27
K850516 HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM Mediatech, Inc. KIT Class I 1985-02-27
K844877 HEPES BUFFER IM IN NORMAL SALINE Hazleton Research Products, Inc. KIP Class I 1985-02-25
K844878 TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG Hazleton Research Products, Inc. KIP Class I 1985-02-25
K841803 A1 SYSTEME 8201/2 Med USA GKL Class II 1985-02-25
K844808 METHYL GREEN-PYRONIN STAIN PROCEDURE HT70 Sigma Chemical Co. HZA Class I 1985-02-25
K844640 POLYSTAT, BIOLOGICAL STAIN Surgipath Medical Industries, Inc. IAB Class I 1985-01-30
K840366 CELL-MATICS HERPES SIMPLEX VIRUS DETECT Difco Laboratories, Inc. KIR Class I 1985-01-08
K843910 COULTER MEAN PLATELET VOLUME CALIBRATOR Coulter Electronics, Inc. KRY Class II 1985-01-07
K844402 SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR Sigma Chemical Co. GIA Class I 1985-01-04
K843727 LEUKOSTIX REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. LJX Class I 1985-01-04
K843601 ACCESS HEMAWIPE Medtech Products, Inc. KHE Class II 1985-01-04
K842218 ANTI-LEU-4 FITC LYSIN C BUFFER Bd Becton Dickinson Vacutainer Systems Preanalytic LIZ Class II 1984-12-27
K843805 COULTER CHECK SAMPLE UNASSAYED HEMATOLOG Coulter Electronics, Inc. JPK Class II 1984-12-17
K843695 QCA HEMOGLOBIN KIT Bd Becton Dickinson Vacutainer Systems Preanalytic KRZ Class II 1984-12-17
K844288 INRA MENEZO B2 MEDIA Fcs Laboratories, Inc. KIT Class I 1984-12-13
K843459 HEMOTEC ACT I SYSTEM Hemotec, Inc. JBP Class II 1984-12-12
K843535 ORTHO BRAIN THROMBOPLASTIN DILUENT Ortho Diagnostic Systems, Inc. GJS Class II 1984-12-12
K843532 UROPAPER EIKEN 8 Syn-Kit, Inc. KHE Class II 1984-12-12
K843485 TRI-COUNT LASER Hematology Marketing Assoc. JPK Class II 1984-12-12

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