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510(k) K072827

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE by Remel, Inc. — Product Code MJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2007
Date Received
October 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antifungal, Susceptibility Test
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

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