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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K960997
Device Name STARSWAB 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 Number866.2900
Classification Product Code
LIO  
Date Received03/12/1996
Decision Date 04/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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