CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)— 510(k) K864373

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K864373 for CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION), Substantially Equivalent on 1987-01-09. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant
Unipath , Ltd.
Product code
Product code LCX
Device class
Class 2
Regulation
21 CFR 862.1155
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bedford Mk41 Oqg, GB
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