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510(k) K082141

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 by Biokit, S.A. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2008
Date Received
July 30, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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