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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 K943499
Device Name KULTSURE STARSWAB(M240), MODIFICATION
Applicant
Ncs Diagnostics, Inc.
50 Steinway Blvd.
Etobicoke, Ontario,  CA M9W 6Y3
Applicant Contact MEHDI KARAMCHI
Correspondent
Ncs Diagnostics, Inc.
50 Steinway Blvd.
Etobicoke, Ontario,  CA M9W 6Y3
Correspondent Contact MEHDI KARAMCHI
Regulation Number866.2390
Classification Product Code
JSM  
Date Received06/13/1994
Decision Date 11/30/1994
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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