STAPHYTECT-OD— 510(k) K940557

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K940557 for STAPHYTECT-OD, Substantially Equivalent on 1994-07-28. Applicant: Unipath , Ltd.. Device class: 1.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code LHJ
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 1994-02-07
Decision date: 1994-07-28
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.