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510(k) K781020

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

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

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  • K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS (April 1, 1982)
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  • K811806 — QUICK-CHEM COLORIMETER (July 15, 1981)
  • K810861 — CREATINE KINASE MB ISOENZYME IMMUNO UV (April 14, 1981)
  • K810727 — AST-UV (PLP-ACTIVATED) DETERMINATION (March 31, 1981)

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