Cleared Traditional

TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

K172257 · True Diagnostics, Inc. · Chemistry

Dec 2017

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K172257 is an FDA 510(k) clearance for the TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format), a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by True Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 22, 2017, 149 days after receiving the submission on July 26, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K172257 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2017
Decision Date	December 22, 2017
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF