Cleared Traditional

Access Total ?hCG (5th IS)

K221990 · Beckman Coulter, Inc. · Chemistry
Dec 2022
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K221990 is an FDA 510(k) clearance for the Access Total ?hCG (5th IS), a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 27, 2022, 174 days after receiving the submission on July 6, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K221990 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2022
Decision Date December 27, 2022
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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