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FDA 510(k) Application Details - K032194
Device Classification Name
Dna-Reagents, Neisseria
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510(K) Number
K032194
Device Name
Dna-Reagents, Neisseria
Applicant
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121-4362 US
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Contact
WAYNE A KVETKOSKY
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Regulation Number
866.3390
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Classification Product Code
LSL
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More FDA Info for this Product Code
Date Received
07/18/2003
Decision Date
12/24/2003
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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