JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
JJG
Device Class
Class I
Regulation Number
862.2140
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972409landmark scientificAG CHEMISTRY ANALYZER SYSTEMAugust 28, 1997
K942782abaxisPICCOLO(TM)March 13, 1995
K934592abaxisEPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORApril 6, 1994
K920942olympusOLYMPUS AU800 CLINICAL CHEMISTRY ANALYZERJune 10, 1992
K910222roche diagnostic systemsCOBAS ALPHAFebruary 27, 1991
K903626beckman instrumentsBIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISAOctober 15, 1990
K893854roche diagnostic systemsCOBAS FARA II CENTRIFUGAL ANALYZERAugust 3, 1989
K893641roche diagnostic systemsCOBAS FARA CENTRIFUGAL ANALYZERJuly 20, 1989
K885203technicon instrumentsTECHNICON DAX(TM) SYSTEMMarch 28, 1989
K871973instrumentation laboratoryIL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.June 11, 1987
K871838beckman instrumentsBIOMEK 1000C AUTOMATED LABORATORY WORK STATIONMay 26, 1987
K854523e.i. dupont de nemours and coANALYST PHYSICIAN'S OFFICE PROFILERJanuary 8, 1986
K854055integrated computerized laboratory systemsI.C.L.S. COMPULYZERNovember 19, 1985
K851619electro-cucleonicsGEN PROFILER SYSTEMMay 14, 1985
K843914roche diagnostic systemsCOBAS FLUORESCENCE POLARIZATION MODULENovember 27, 1984
K842522abbott laboratoriesPDA SYSTEMAugust 2, 1984
K840231consumable lab suppliesDISPOSABLE CUVETTE ARRAYMarch 22, 1984
K832716baker instructionsENCORE CHEMISTRY ANALYZEROctober 4, 1983
K831571american scientific productsROTORJune 30, 1983
K831569american scientific productsREAGENT CUPSJune 30, 1983