CLEARPLAN EASY FERTILITY MONITOR— 510(k) K981207

Name: FDA 510(k) clearance K981207
Creator: U.S. Food and Drug Administration
Published: 1998-10-28

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K981207 for CLEARPLAN EASY FERTILITY MONITOR, Substantially Equivalent on 1998-10-28. Applicant: Unipath , Ltd.. Device class: 1.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code NGE
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1998-04-02
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, GB

Download summary PDF View on FDA.gov ↗

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