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510(k) K883389

RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD by Reagents Applications, Inc. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1988
Date Received
August 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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