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510(k) K060364

VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE by Teco Diagnostics — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2006
Date Received
February 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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