510(k) K110413

POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS by Beckman Coulter, Inc. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2011
Date Received
February 14, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type