SELFCARE EARLY PREGNANCY TEST— 510(k) K960436

Substantially Equivalent

Selfcare, Inc.

FDA 510(k) clearance K960436 for SELFCARE EARLY PREGNANCY TEST, Substantially Equivalent on 1996-03-19. Applicant: Selfcare, Inc.. Device class: 2.

Clearance details

Applicant
Selfcare, Inc.
Product code
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
Galway, IE
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