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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 K874019
Device Name STAPHSLIDE
Applicant
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Applicant Contact ALLEN CHAN
Correspondent
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Correspondent Contact ALLEN CHAN
Regulation Number866.2660
Classification Product Code
JWX  
Date Received10/02/1987
Decision Date 10/28/1987
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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