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FDA 510(k) Applications for Medical Device Product Code "PQO"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K223679
Beckman Coulter Inc
Access AMH
02/03/2023
K170524
Beckman Coulter, Inc.
Access AMH
11/13/2017
K203757
Roche Diagnostics
Elecsys AMH
06/10/2022
DEN150057
ROCHE DIAGNOSTICS
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
12/19/2016
K221801
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur« Anti-Mⁿllerian Hormone (AMH)
06/02/2023
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