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510(k) K103716

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET by Roche Diagnostics — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2011
Date Received
December 21, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

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