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FDA 510(k) Application Details - K993554
Device Classification Name
Kit, Identification, Yeast
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
866.2660
More FDA Info for this Regulation Number
Classification Product Code
JXB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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