CHOLESTEROL-E (TOTAL)— 510(k) K863062

Substantially Equivalent

J. D. Assoc.

FDA 510(k) clearance K863062 for CHOLESTEROL-E (TOTAL), Substantially Equivalent on 1986-09-25. Applicant: J. D. Assoc.. Device class: 1.

Clearance details

Applicant: J. D. Assoc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1986-08-12
Decision date: 1986-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

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