FDA 510(k) Application Details - K051929

Device Classification Name Cryptosporidium Spp.

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510(K) Number K051929
Device Name Cryptosporidium Spp.
Applicant TECHLAB, INC.
2001 KRAFT DR.
BLACKSBURG, VA 24060-6358 US
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Contact DAVID M LYRLY
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Regulation Number 866.3220

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Classification Product Code MHJ
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Date Received 07/13/2005
Decision Date 11/17/2005
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

FDA Source Information for K051929


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