SIGMA REAGENT SYSTEM NO. 885— 510(k) K822733

Name: FDA 510(k) clearance K822733
Creator: U.S. Food and Drug Administration
Published: 1982-12-03

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K822733 for SIGMA REAGENT SYSTEM NO. 885, Substantially Equivalent on 1982-12-03. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code JBE
Device class: Class 2
Regulation: 21 CFR 864.7100
Advisory panel: Hematology
Date received: 1982-09-08
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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