Cleared Traditional

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

K152768 · Assure Tech. Co., Ltd. · Chemistry
Feb 2016
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K152768 is an FDA 510(k) clearance for the Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Assure Tech. Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 24, 2016, 153 days after receiving the submission on September 24, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K152768 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2015
Decision Date February 24, 2016
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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