QACA IGG/IGM ELISA KIT HRP— 510(k) K021192

Name: FDA 510(k) clearance K021192
Creator: U.S. Food and Drug Administration
Published: 2002-05-16

Substantially Equivalent

Cheshire Diagnostics , Ltd.

FDA 510(k) clearance K021192 for QACA IGG/IGM ELISA KIT HRP, Substantially Equivalent on 2002-05-16. Applicant: Cheshire Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Cheshire Diagnostics , Ltd.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2002-04-15
Decision date: 2002-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellesmere Port, GB

Download summary PDF View on FDA.gov ↗

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