Access Myoglobin
K-Number: K231832 · 2023-09-18
ApplicantBeckman Coulter, Inc.
Decision Date2023-09-18
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Access Myoglobin is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-09-18 under approval number K231832. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access Myoglobin?
Access Myoglobin is a medical device that received FDA 510(k) clearance on 2023-09-18. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K231832.
When was Access Myoglobin approved by the FDA?
Access Myoglobin received FDA 510(k) clearance on 2023-09-18, under approval number K231832.
What company makes Access Myoglobin?
Access Myoglobin is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Myoglobin?
The FDA product code for Access Myoglobin is DDR.
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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.