UREA NITROGEN REAGENT SET— 510(k) K821212

Name: FDA 510(k) clearance K821212
Creator: U.S. Food and Drug Administration
Published: 1982-07-22

Substantially Equivalent

Omega Medical Electronics

FDA 510(k) clearance K821212 for UREA NITROGEN REAGENT SET, Substantially Equivalent on 1982-07-22. Applicant: Omega Medical Electronics. Device class: 2.

Clearance details

Applicant: Omega Medical Electronics
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1982-04-27
Decision date: 1982-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #13461986-10-01
K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11

More clearances from Omega Medical Electronics

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K823691 — PHOSPHORUS REAGENT SET1983-01-07
K821204 — GLUCOSE(ENZYMATIC) REAGENT SET1982-07-22
K821206 — SGPT-UV REAGENT SET1982-07-22
K821201 — LDH-UV REAGENT SET1982-07-20
K821205 — TRIGLYCERIDE REAGENT SET1982-07-20

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