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510(k) K043327

ONLINE DAT BENZODIAZEPINES PLUS by Roche Diagnostics Corp. — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2005
Date Received
December 2, 2004
Clearance Type
Traditional
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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