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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 K972030
Device Name STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
Applicant
OXOID, LTD.
WADE RD.
BASINGSTOKE, HAMPSHIRE,  GB RG24 8PW
Applicant Contact ANDY HOLLINGSWORTH
Correspondent
OXOID, LTD.
WADE RD.
BASINGSTOKE, HAMPSHIRE,  GB RG24 8PW
Correspondent Contact ANDY HOLLINGSWORTH
Regulation Number866.2660
Classification Product Code
JWX  
Date Received06/02/1997
Decision Date 09/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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