510(k) K780148

RIA FOR FOLATES & VIT. B12, COMBO KIT by Ria Products, Inc. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1978
Date Received
January 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type