ROTASCREEN— 510(k) K872568

Substantially Equivalent

Mercia Diagnostics , Ltd.

FDA 510(k) clearance K872568 for ROTASCREEN, Substantially Equivalent on 1987-09-14. Applicant: Mercia Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Mercia Diagnostics , Ltd.
Product code: Code GOB
Device class: Class 1
Regulation: 21 CFR 866.3020
Advisory panel: Microbiology
Date received: 1987-06-29
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, Surrey England, GB

Download summary PDF View on FDA.gov ↗

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