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510(k) K051297

ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK by Roche Diagnostics Corp. — Product Code NEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2005
Date Received
May 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Osteocalcin
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

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Other clearances for product code NEO

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