510(k) K961276

GASTRIN EIA MODEL 06B-555017 by Biosyn , Ltd. — Product Code CGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
April 3, 1996
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