Cleared Traditional

INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

K192843 · Innovita (Tangshan) Biological Technology Co., Ltd. · Chemistry
Nov 2019
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K192843 is an FDA 510(k) clearance for the INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Innovita (Tangshan) Biological Technology Co., Ltd. (Qian?An, CN). The FDA issued a Cleared decision on November 22, 2019, 50 days after receiving the submission on October 3, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K192843 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2019
Decision Date November 22, 2019
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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