510(k) K980667— INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)

Substantially Equivalent

Sigma Diagnostics, Inc.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 1998-02-20
Decision date: 1998-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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