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510(k) K854187

IN-VITRO TEST DETERMINATION OF SGOT (AST) by Clinical Data, Inc. — Product Code CIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1985
Date Received
October 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code CIS

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  • K812872 — OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (October 26, 1981)
  • K792410 — ELVI SGOT & SGPT TRANSAMINASE (December 6, 1979)