510(k) K110413

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

K110413 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS". The FDA issued a decision of Substantially Equivalent on May 11, 2011. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.

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