510(k) K182328— VeriClear Digital Early Result Pregnancy Test

Substantially Equivalent

True Diagnostics, Inc.

Clearance details

Applicant: True Diagnostics, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2018-08-27
Decision date: 2019-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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