ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)— 510(k) K181082

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K181082 for ADVIA Chemistry Cystatin C_2 Assay (CYSC_2), Substantially Equivalent on 2018-05-25. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code NDY
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, NJ, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.