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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 K060364
Device Name VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
Applicant
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact JIAN VAECHES
Correspondent
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact JIAN VAECHES
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/13/2006
Decision Date 06/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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