510(k) K821175

GASTRIN RADIOIMMUNOASSAY KIT (125-I) by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1982
Date Received
April 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gastrin
Device Class
Class I
Regulation Number
862.1325
Review Panel
CH
Submission Type