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FDA 510(k) Application Details - K993033
Device Classification Name
Culture Media, For Isolation Of Pathogenic Neisseria
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510(K) Number
K993033
Device Name
Culture Media, For Isolation Of Pathogenic Neisseria
Applicant
BIOMED DIAGNOSTICS, INC.
1430 KOLL CIRCLE, SUITE 101
SAN JOSE, CA 95112 US
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Contact
ROBERT D HALL
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Regulation Number
866.2410
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Classification Product Code
JTY
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More FDA Info for this Product Code
Date Received
09/09/1999
Decision Date
12/16/1999
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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