ROTASCREEN EIA— 510(k) K873740

Substantially Equivalent

Mercia Diagnostics , Ltd.

FDA 510(k) clearance K873740 for ROTASCREEN EIA, Substantially Equivalent on 1987-11-27. Applicant: Mercia Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Mercia Diagnostics , Ltd.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1987-09-15
Decision date: 1987-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, Surrey England, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIQ

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K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05

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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.