CHEM-STRATE CHOLESTEROL— 510(k) K792478

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K792478 for CHEM-STRATE CHOLESTEROL, Substantially Equivalent on 1979-12-27. Applicant: General Diagnostics. Device class: 1.

Clearance details

Applicant: General Diagnostics
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1979-12-03
Decision date: 1979-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.