ENZYMATIC CHOLESTEROL— 510(k) K771820

Substantially Equivalent

Macomb Chemical Co.

FDA 510(k) clearance K771820 for ENZYMATIC CHOLESTEROL, Substantially Equivalent on 1977-10-19. Applicant: Macomb Chemical Co.. Device class: 1.

Clearance details

Applicant: Macomb Chemical Co.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-09-23
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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