MODIFIED CAPTIA(R) SYPHILIS-M— 510(k) K900654

Name: FDA 510(k) clearance K900654
Creator: U.S. Food and Drug Administration
Published: 1990-03-08

Substantially Equivalent

Mercia Diagnostics , Ltd.

FDA 510(k) clearance K900654 for MODIFIED CAPTIA(R) SYPHILIS-M, Substantially Equivalent on 1990-03-08. Applicant: Mercia Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Mercia Diagnostics , Ltd.
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1990-02-09
Decision date: 1990-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, Surrey England, GB

Download summary PDF View on FDA.gov ↗

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