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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K871404
Device Name KULTSURE
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 Number866.2390
Classification Product Code
JSM  
Date Received04/08/1987
Decision Date 04/21/1987
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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