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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 Somatic Antigens
510(k) Number K863025
Device Name SERO-STAT R II STAPHYLOCOCCUS TEST
Applicant
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Applicant Contact PAUL CAMPOGNONE
Correspondent
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Correspondent Contact PAUL CAMPOGNONE
Regulation Number866.3700
Classification Product Code
LHT  
Date Received08/11/1986
Decision Date 09/15/1986
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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