PHOSPHORUS REAGENT SET— 510(k) K823691

Name: FDA 510(k) clearance K823691
Creator: U.S. Food and Drug Administration
Published: 1983-01-07

Substantially Equivalent

Omega Medical Electronics

FDA 510(k) clearance K823691 for PHOSPHORUS REAGENT SET, Substantially Equivalent on 1983-01-07. Applicant: Omega Medical Electronics. Device class: 1.

Clearance details

Applicant: Omega Medical Electronics
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1982-12-08
Decision date: 1983-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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