TURBOX FIBRINOGEN— 510(k) K884179

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K884179 for TURBOX FIBRINOGEN, Substantially Equivalent on 1988-12-20. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Product code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1988-09-30
Decision date: 1988-12-20
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.