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510(k) K111762

ST AIA-PACK DHEA-S CALIBRATOR SET by Tosoh Bioscience, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2011
Date Received
June 23, 2011
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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