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510(k) K140496

Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents by Beckman Coulter, Inc. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2014
Date Received
February 27, 2014
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

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