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510(k) K800688

REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC by Diagnostic Solutions, Inc. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
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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  • K800687 — REAGENT FOR DETERM. GLUCOSE IN H/SERUM (May 28, 1980)
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  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)
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