FDA 510(k)

Access Intrinsic Factor Ab

K-Number: K240800 · 2024-05-03

Decision Date2024-05-03

Product CodeLIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Access Intrinsic Factor Ab is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-05-03 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240800.

When did Access Intrinsic Factor Ab receive FDA 510(k) clearance?

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

Who is the listed applicant for Access Intrinsic Factor Ab?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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