510(k) K150063— One Step hCG Pregnancy Test

Substantially Equivalent

Coretests, Inc.

Clearance details

Applicant: Coretests, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2015-01-13
Decision date: 2015-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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