FDA 510(k) Application Details - K993554

Device Classification Name Kit, Identification, Yeast

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510(K) Number K993554
Device Name Kit, Identification, Yeast
Applicant DIAGNOSTIC MARKERS, INC.
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GREG HOLLAND
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Regulation Number 866.2660

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Classification Product Code JXB
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Date Received 10/20/1999
Decision Date 02/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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