510(k) K760348

REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 by Sigma Chemical Co. — Product Code CCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1976
Date Received
August 2, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Zimmerman/Norymberski, 17-Ketogenic Steroids
Device Class
Class I
Regulation Number
862.1385
Review Panel
CH
Submission Type