Cleared Traditional

Access Ostase

K232904 · Beckman Coulter · Chemistry
Apr 2024
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K232904 is an FDA 510(k) clearance for the Access Ostase, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Beckman Coulter (Chaska, US). The FDA issued a Cleared decision on April 15, 2024, 210 days after receiving the submission on September 18, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K232904 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2023
Decision Date April 15, 2024
Days to Decision 210 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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