510(k) K200210

Device
ADVIA Centaur® Total hCG assay
Applicant
Siemens Healthcare Diagnostics, Inc.
510(k) number
K200210
Product code
DHA
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-13
Date received
2020-01-28
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
No

Related Records

Applicant Contact

Contact
Mey Lyn Vasquez
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers

Source Documents

510(k) summary PDF

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