COLORIMETRIC DETERM. SOCITRATE DEHYDRO.— 510(k) K770902

Name: FDA 510(k) clearance K770902
Creator: U.S. Food and Drug Administration
Published: 1977-07-14

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K770902 for COLORIMETRIC DETERM. SOCITRATE DEHYDRO., Substantially Equivalent on 1977-07-14. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code JKH
Device class: Class 1
Regulation: 21 CFR 862.1420
Advisory panel: Clinical Chemistry
Date received: 1977-05-16
Decision date: 1977-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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