ALBUMIN IN URINE— 510(k) K873861

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K873861 for ALBUMIN IN URINE, Substantially Equivalent on 1987-10-13. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 1987-08-24
Decision date: 1987-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Mk41 Oqg, GB

Download summary PDF View on FDA.gov ↗

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