FDA 510(k)

Access AMH

K-Number: K170524 · 2017-11-13

Decision Date2017-11-13

Product CodePQO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Access AMH 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 2017-11-13 under 510(k) number K170524. The device is classified under product code PQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access AMH?

Access AMH is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K170524.

When did Access AMH receive FDA 510(k) clearance?

Access AMH received FDA 510(k) clearance on 2017-11-13, under 510(k) number K170524.

Who is the listed applicant for Access AMH?

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 AMH?

The FDA product code for Access AMH is PQO.

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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Related Devices (Code: PQO)

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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.