JQX — Nephelometer, For Clinical Use Class I

FDA Device Classification

FDA product code JQX covers "Nephelometer, For Clinical Use", a Class I medical device regulated under 21 CFR 862.2700. Submissions are reviewed by the Clinical Chemistry panel. At least 14 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JQX
Device Class
Class I
Regulation Number
862.2700
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962294beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEMAugust 21, 1996
K922273beckman instrumentsARRAY(R) 360August 19, 1992
K885263seradynQMS(TM) - THEOPHYLLINEMarch 28, 1989
K851253abbott laboratoriesTDX ANALYZER W/NEPHELOMETRY CAROUSELApril 30, 1985
K851234abbott laboratoriesA-JUST TURBIDITY METERApril 29, 1985
K801362j.t. baker chemicalALBUMIN NEPHELOMETRIC ASSAYJuly 21, 1980
K801089j.t. baker chemicalJ.T. BAKER NEPHELOMETERMay 28, 1980
K792045biovationBIOVATION NEPHELOMETEROctober 30, 1979
K790103dynatechNEPHELOMETER, MIC-2000 LASERMarch 12, 1979
K781554organonRAD-291October 11, 1978
K781644biovationANTIBIOTIC NEPHELOMETEROctober 3, 1978
K780251kallestad laboratoriesNEPHELOMETERApril 6, 1978
K772361g.d. searle andLASER IMMUNONEPHELOMETRIC ANALYZERJanuary 30, 1978
K771446hyland therapeutic div., travenol laboratoriesTRANSPORTEO MODULEAugust 10, 1977