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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staphylococcus Aureus Protein A Insoluble
510(k) Number K940557
Device Name STAPHYTECT-OD
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact Louise Roberts
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact Louise Roberts
Regulation Number866.3700
Classification Product Code
LHJ  
Date Received02/07/1994
Decision Date 07/28/1994
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
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