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FDA 510(k) Application Details - K960759
Device Classification Name
Kit, Identification, Neisseria Gonorrhoeae
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510(K) Number
K960759
Device Name
Kit, Identification, Neisseria Gonorrhoeae
Applicant
MEDTEX LABORATORIES, INC.
10215 LAKE CITY WAY, N.E.
SUITE F
SEATTLE, WA 98125 US
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Contact
KIRK C S. CHEN
Other 510(k) Applications for this Contact
Regulation Number
866.2660
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Classification Product Code
JSX
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More FDA Info for this Product Code
Date Received
02/26/1996
Decision Date
09/18/1996
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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