CREATININE-E— 510(k) K863078

Substantially Equivalent

J. D. Assoc.

FDA 510(k) clearance K863078 for CREATININE-E, Substantially Equivalent on 1986-09-09. Applicant: J. D. Assoc.. Device class: 2.

Clearance details

Applicant: J. D. Assoc.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1986-08-12
Decision date: 1986-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

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