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510(k) K051307

SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT by Beckman Coulter, Inc. — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2005
Date Received
May 19, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

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