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510(k) K140648

ST AIA-PACK C-PEPTIDE II CALIBRATOR SET by Tosoh Bioscience, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2014
Date Received
March 13, 2014
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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