REAGENT SYSTEM, NO 46-OV FOR CPK— 510(k) K781859

Name: FDA 510(k) clearance K781859
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K781859 for REAGENT SYSTEM, NO 46-OV FOR CPK, Substantially Equivalent on 1978-12-04. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1978-11-06
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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