UREA NITROGEN-BUN-REAGENTS B6360-12— 510(k) K831625

Name: FDA 510(k) clearance K831625
Creator: U.S. Food and Drug Administration
Published: 1983-07-07

Substantially Equivalent

American Scientific Products

FDA 510(k) clearance K831625 for UREA NITROGEN-BUN-REAGENTS B6360-12, Substantially Equivalent on 1983-07-07. Applicant: American Scientific Products. Device class: 2.

Clearance details

Applicant: American Scientific Products
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1983-05-20
Decision date: 1983-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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