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510(k) K062604

RAPIDTEG TEG-ACT TEST by Haemoscope Corp. — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2007
Date Received
September 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

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  • K954437 — THROMBELASTOGRAPH COAGULATION ANALYZER 3000S (January 30, 1996)
  • K904204 — THROMBELASTOGRAPH (November 1, 1990)
  • K895844 — THROMBELASTOGRAPH(R) (October 24, 1989)

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