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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
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