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FDA 510(k)

Access Intrinsic Factor Ab

K-Number: K240800 · 2024-05-03

ApplicantBeckman Coulter, Inc.
Decision Date2024-05-03
Product CodeLIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Intrinsic Factor Ab is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-05-03 under approval number K240800. The device is classified under product code LIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Intrinsic Factor Ab?

Access Intrinsic Factor Ab is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K240800.

When was Access Intrinsic Factor Ab approved by the FDA?

Access Intrinsic Factor Ab received FDA 510(k) clearance on 2024-05-03, under approval number K240800.

What company makes Access Intrinsic Factor Ab?

Access Intrinsic Factor Ab is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Intrinsic Factor Ab?

The FDA product code for Access Intrinsic Factor Ab is LIG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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