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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K924361
Device Name VACUPLUS TUBES WITH GREEN STOPPERS
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 Number862.1675
Classification Product Code
JKA  
Date Received08/28/1992
Decision Date 03/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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