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)— 510(k) K172257

Name: FDA 510(k) clearance K172257
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Substantially Equivalent

True Diagnostics, Inc.

FDA 510(k) clearance K172257 for 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), Substantially Equivalent on 2017-12-22. Applicant: True Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: True Diagnostics, Inc.
Product code: Code JHI
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2017-07-26
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K172322 — Atellica IM Total hCG (ThCG)2018-03-29
K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip2016-02-24
K130456 — WUNDER PREGNANCY TEST2014-04-08

More clearances from True Diagnostics, Inc.

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K182328 — VeriClear Digital Early Result Pregnancy Test2019-05-15

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.