UCG-BETA STAT— 510(k) K802421

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K802421 for UCG-BETA STAT, Substantially Equivalent on 1980-10-23. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1980-10-06
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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