SIGMA PROCEDURE 265-UV— 510(k) K811864

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K811864 for SIGMA PROCEDURE 265-UV, Substantially Equivalent on 1981-07-31. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code CED
Device class: Class 1
Regulation: 21 CFR 862.1520
Advisory panel: Clinical Chemistry
Date received: 1981-07-01
Decision date: 1981-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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