IDEIA PCE CHLAMYDIA— 510(k) K033865

Substantially Equivalent

Dakocytomation, Ltd.

FDA 510(k) clearance K033865 for IDEIA PCE CHLAMYDIA, Substantially Equivalent on 2004-01-21. Applicant: Dakocytomation, Ltd.. Device class: 1.

Clearance details

Applicant: Dakocytomation, Ltd.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 2003-12-12
Decision date: 2004-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Ely, Cambridgeshire, GB

Download summary PDF View on FDA.gov ↗

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