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510(k) K041502

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY by Haemoscope Corp. — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2004
Date Received
June 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

Other clearances by Haemoscope Corp.

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  • K993678 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES (May 5, 2000)
  • K954437 — THROMBELASTOGRAPH COAGULATION ANALYZER 3000S (January 30, 1996)
  • K904204 — THROMBELASTOGRAPH (November 1, 1990)
  • K895844 — THROMBELASTOGRAPH(R) (October 24, 1989)

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