Cleared Traditional

Alltest Pregnancy Rapid Combo Test Cassette

K203272 · Hangzhou AllTest Biotech Co., Ltd. · Chemistry
Jan 2022
Decision
451d
Days
Class 2
Risk

About This 510(k) Submission

K203272 is an FDA 510(k) clearance for the Alltest Pregnancy Rapid Combo Test Cassette, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 31, 2022, 451 days after receiving the submission on November 6, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K203272 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2020
Decision Date January 31, 2022
Days to Decision 451 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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