FDA.report

510(k) K233663

Device
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Applicant
Siemens Healthcare Diagnostics Products GmbH
510(k) number
K233663
Product code
CFN
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-13
Date received
2023-11-15
Regulation
866.5510
Classification name
Method, Nephelometric, Immunoglobulins (G, A, M)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Sanja Matern
Address
Emil-Von-Behring-Str. 76 Marburg DE 35041 35041

FDA Registration Numbers

Source Documents

510(k) summary PDF

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