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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K923212
Device Name SLIDEX STAPH-KIT
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2395
Applicant Contact DAVID K BROADWAY
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2395
Correspondent Contact DAVID K BROADWAY
Regulation Number866.2660
Classification Product Code
JWX  
Date Received07/01/1992
Decision Date 09/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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