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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 K032246
Device Name MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
Applicant
Starplex Scientific, Inc.
50 Steinway Blvd.
Unit #5
Etobicoke, Ontario,  CA M9W 6Y3
Applicant Contact MEHDI KARAMCHI
Correspondent
Starplex Scientific, Inc.
50 Steinway Blvd.
Unit #5
Etobicoke, Ontario,  CA M9W 6Y3
Correspondent Contact MEHDI KARAMCHI
Regulation Number866.2390
Classification Product Code
JSM  
Date Received07/22/2003
Decision Date 08/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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