Cleared Traditional

Innovita HCG Pregnancy Rapid Combo Test

K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · Chemistry
Aug 2024
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K241919 is an FDA 510(k) clearance for the Innovita HCG Pregnancy Rapid Combo Test, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Innovita (Tangshan) Biological Technology Co., Ltd. (Qian'An, CN). The FDA issued a Cleared decision on August 2, 2024, 32 days after receiving the submission on July 1, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K241919 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date August 02, 2024
Days to Decision 32 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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