FDA 510(k) Application Details - K955755

Device Classification Name Cryptosporidium Spp.

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510(K) Number K955755
Device Name Cryptosporidium Spp.
Applicant TREND SCIENTIFIC, INC.
368 WEST COUNTY RD. D
NEW BRIGHTON, MN 55112 US
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Contact MARIELLYN TRUAX
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Regulation Number 866.3220

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Classification Product Code MHJ
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Date Received 12/20/1995
Decision Date 07/11/1996
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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