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510(k) K223289

Access Vitamin B12 by Beckman Coulter, Inc. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2022
Date Received
October 25, 2022
Clearance Type
Traditional
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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