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510(k) K002177

THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES by Haemoscope Corp. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2000
Date Received
July 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
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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