INFINITY AST REAGENT (PROCEDURE NO. 51)— 510(k) K980666

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K980666 for INFINITY AST REAGENT (PROCEDURE NO. 51), Substantially Equivalent on 1998-03-20. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CIT
Advisory panel: Clinical Chemistry
Date received: 1998-02-20
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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