UREA NITROGEN-UV— 510(k) K833931

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K833931 for UREA NITROGEN-UV, Substantially Equivalent on 1984-01-13. Applicant: Seragen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1983-11-14
Decision date: 1984-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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