510(k) K832790

SERALYZER AST/SGOT REAGENT STRIPS by Miles Laboratories, Inc. — Product Code CIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vanillin Pyruvate, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type