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510(k) K043318

MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY by Roche Diagnostics Corp. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2004
Date Received
December 2, 2004
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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