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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 K854278
Device Name NEG COMBO BREAKPOINT PANEL POS COMBO
Applicant
American Micro Scan
855 57th. St. Suite G
Sacramento,  CA  95819
Applicant Contact KRISTA L UNDERWOOD
Correspondent
American Micro Scan
855 57th. St. Suite G
Sacramento,  CA  95819
Correspondent Contact KRISTA L UNDERWOOD
Regulation Number866.2660
Classification Product Code
JWX  
Date Received10/24/1985
Decision Date 03/04/1986
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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