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510(k) K062604

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

K062604 is an FDA 510(k) premarket notification submitted by Haemoscope Corp. for the device "RAPIDTEG TEG-ACT TEST". The FDA issued a decision of Substantially Equivalent on January 31, 2007. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Haemoscope Corp. has at least 6 other 510(k) clearances on record.

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

Other clearances by Haemoscope Corp.

  • K041502 — THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY (September 1, 2004)
  • K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (September 14, 2000)
  • 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)

Other clearances for product code JBP

  • K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (January 4, 2023)
  • K032952 — AIACT KIT (December 12, 2003)
  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (May 23, 2002)
  • K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (January 10, 2002)
  • K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O (August 31, 2000)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST (January 14, 2000)
  • K984141 — GBACT + KIT (May 28, 1999)

FDA data resources