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FDA 510(k) Application Details - K132235
Device Classification Name
More FDA Info for this Device
510(K) Number
K132235
Device Name
IMDX C.DIFFICILE FOR ABBOTT M2000
Applicant
Intelligent Medical Devices, Inc.
180 CABOT ST
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
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Regulation Number
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Classification Product Code
OZN
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Date Received
07/18/2013
Decision Date
10/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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