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

Name: FDA 510(k) clearance K945908
Creator: U.S. Food and Drug Administration
Published: 1995-05-08

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.. Device class: 2.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
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 ↗

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