510(k) K781020

(AST) OR (ALT) UV DETERM. PHY. PHOS. by The Dow Chemical Co. — Product Code CIT

K781020 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "(AST) OR (ALT) UV DETERM. PHY. PHOS.". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 15, 1978
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