Cleared Traditional

Access Intrinsic Factor Ab

K240800 · Beckman Coulter, Inc. · Chemistry
May 2024
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K240800 is an FDA 510(k) clearance for the Access Intrinsic Factor Ab, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 3, 2024, 39 days after receiving the submission on March 25, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K240800 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2024
Decision Date May 03, 2024
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LIG — Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

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