510(k) K110874

ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR by Siemens Healthcare Diagnostics, Inc. — Product Code JZG

K110874 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
March 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Beta-2-Microglobulin Immunological
Device Class
Class II
Regulation Number
866.5630
Review Panel
IM
Submission Type