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510(k) K070709

ROCHE ELECSYS PTH TEST SYSTEM by Roche Diagnostics Corp. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2007
Date Received
March 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

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