Access AMH
K-Number: K170524 · 2017-11-13
ApplicantBeckman Coulter, Inc.
Decision Date2017-11-13
Product CodePQO
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Access AMH is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2017-11-13 under approval 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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K170524.
When was Access AMH approved by the FDA?
Access AMH received FDA 510(k) clearance on 2017-11-13, under approval number K170524.
What company makes Access AMH?
Access AMH is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access AMH?
The FDA product code for Access AMH is PQO.
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K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
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Related Devices (Code: PQO)
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.