PROCEDURE NO. 555— 510(k) K771916

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K771916 for PROCEDURE NO. 555, Substantially Equivalent on 1977-10-19. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1977-10-11
Decision date: 1977-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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