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FDA 510(k) Application Details - K190086
Device Classification Name
More FDA Info for this Device
510(K) Number
K190086
Device Name
Cepheid Xpert Respiratory Control Panel
Applicant
Microbiologics, Inc.
200 Cooper Avenue North
St. Cloud, MN 56303 US
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Contact
Tina Sobania
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Regulation Number
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Classification Product Code
PMN
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Date Received
01/17/2019
Decision Date
10/07/2019
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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