CANDIDATE(R) SUPER— 510(k) K863499

Substantially Equivalent

Mercia Diagnostics , Ltd.

FDA 510(k) clearance K863499 for CANDIDATE(R) SUPER, Substantially Equivalent on 1987-03-19. Applicant: Mercia Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Mercia Diagnostics , Ltd.
Product code: Code LRF
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 1986-09-09
Decision date: 1987-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, Surrey England, GB

Download summary PDF View on FDA.gov ↗

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K900654 — MODIFIED CAPTIA(R) SYPHILIS-M1990-03-08
K896194 — CAPTIA(R) CMV-G1990-03-06
K896295 — CAPTIA(R) CMV-M1990-03-06

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