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510(k) K063232

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 by Biokit, S.A. — Product Code CEW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 19, 2007
Date Received: October 25, 2006
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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