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510(k) K880276

AST (SGOT) REAGENT SET by Tech-Neal Scientific, Inc. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1988
Date Received
January 21, 1988
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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  • K880237 — CHOLESTEROL (April 28, 1988)
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  • K880842 — LDH-L REAGENT SET (April 5, 1988)
  • K880844 — ALBUMIN REAGENT SET (April 5, 1988)

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