FDA 510(k) Application Details - K052932

Device Classification Name Cryptosporidium Spp.

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510(K) Number K052932
Device Name Cryptosporidium Spp.
Applicant TECHLAB, INC.
2001 KRAFT DR.
BLACKSBURG, VA 24060-6358 US
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Contact DAVID M LYERLY
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Regulation Number 866.3220

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Classification Product Code MHJ
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Date Received 10/19/2005
Decision Date 11/04/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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