510(k) K072204

ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS by Siemens Medical Solutions Diagnostics — Product Code JIX

K072204 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS". The FDA issued a decision of Substantially Equivalent on October 5, 2007. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2007
Date Received
August 8, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type