510(k) K932049

STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 by Stanbio Laboratory — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1993
Date Received
April 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type