510(k) K760821

REAGENT SYSTEM by Sigma Chemical Co. — Product Code CJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1976
Date Received
October 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Aldolase
Device Class
Class I
Regulation Number
862.1040
Review Panel
CH
Submission Type