GLUCOSE (HK) REAGENT (PROCEDURE NO.16)— 510(k) K945908

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K945908 for GLUCOSE (HK) REAGENT (PROCEDURE NO.16), Substantially Equivalent on 1995-05-08. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 1994-12-02
Decision date: 1995-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.