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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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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