Cleared Traditional

Access 25(OH) Vitamin D Total

K223503 · Beckman Coulter, Inc. · Chemistry
Jan 2023
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K223503 is an FDA 510(k) clearance for the Access 25(OH) Vitamin D Total, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 19, 2023, 58 days after receiving the submission on November 22, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K223503 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2022
Decision Date January 19, 2023
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRG — System, Test, Vitamin D
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1825

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