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FDA 510(k) Application Details - K171078
Device Classification Name
Cryptosporidium Spp.
More FDA Info for this Device
510(K) Number
K171078
Device Name
Cryptosporidium Spp.
Applicant
Techlab, Inc.
2001 Kraft Drive
Blacksburg, VA 24060-6358 US
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Contact
Donna T. Link
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Regulation Number
866.3220
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Classification Product Code
MHJ
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More FDA Info for this Product Code
Date Received
04/11/2017
Decision Date
07/10/2017
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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