510(k) K221990

Device
Access Total ßhCG (5th IS)
Applicant
Beckman Coulter, Inc.
510(k) number
K221990
Product code
DHA
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-27
Date received
2022-07-06
Regulation
862.1155
Classification name
System, Test, Human Chorionic Gonadotropin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Kate Oelberg
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers

Source Documents

510(k) summary PDF

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