CGC — Radioimmunoassay, Gastrin Class I

FDA Device Classification

Classification Details

Product Code
CGC
Device Class
Class I
Regulation Number
862.1325
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K961276biosynGASTRIN EIA MODEL 06B-555017May 30, 1996
K842079immuno nuclearGASTRIN 34 HORMONE BY RADIOUMMUNOASSAYJune 26, 1984
K841963syncor intlGASTRIN RIAJune 25, 1984
K833489diagnostic productsDPC GASTRIN KITJanuary 30, 1984
K831075united diagnosticsBLOOD GAS & FLAME PHOTOMETER INSTRU-June 22, 1983
K821175bd becton dickinson vacutainer systems preanalyticGASTRIN RADIOIMMUNOASSAY KIT (125-I)May 14, 1982
K812727immuno nuclearGASTRIN 1-17 BY RADIOIMMUNOASSAY KITNovember 5, 1981
K812004abbott laboratoriesGASTRIN RIA DIAGNOSTIC KITJuly 28, 1981
K810722clinical assaysGASTRIN RADIOIMMUNOASSAY TESTMay 27, 1981
K771953inter science instituteGASTRIN RIA MODULEJanuary 20, 1978