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510(k) K913410

EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS by Syva Co. — Product Code DMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1991
Date Received
July 31, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type

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