Cleared Traditional

Access Intact PTH

K232791 · Beckman Coulter, Inc. · Chemistry
Mar 2024
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K232791 is an FDA 510(k) clearance for the Access Intact PTH, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on March 1, 2024, 172 days after receiving the submission on September 11, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K232791 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2023
Decision Date March 01, 2024
Days to Decision 172 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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