INFINITY GLUCOSE REAGENT— 510(k) K984574

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K984574 for INFINITY GLUCOSE REAGENT, Substantially Equivalent on 1999-02-11. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 1998-12-23
Decision date: 1999-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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