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510(k) K051292

ELECSYS RBC FOLATE HEMOLYZED REAGENT by Roche Diagnostics Corp. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2005
Date Received
May 18, 2005
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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