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FDA 510(k) Application Details - K231223
Device Classification Name
More FDA Info for this Device
510(K) Number
K231223
Device Name
MDx-Chex for BC-GN
Applicant
Streck
7002 S. 109th Street
La Vista, NE 68128 US
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Contact
Cody A. Janssen
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PMN
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More FDA Info for this Product Code
Date Received
04/28/2023
Decision Date
07/27/2023
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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