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510(k) K981206

TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) by Cardiovascular Diagnostics, Inc. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1998
Date Received
April 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation, Automated
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Cardiovascular Diagnostics, Inc.

  • K013305 — ENOXAPARIN TEST CARD (August 23, 2002)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K994159 — HMP CONTROLS (TAS) RAPIDPOINT (February 15, 2000)
  • K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOIN (January 14, 2000)
  • K990566 — TAS ANALYZER, MODEL 1009 (May 14, 1999)
  • K981178 — THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS (April 27, 1998)
  • K971748 — TAS PT-NCTEST CONTROLS (May 29, 1997)
  • K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (August 13, 1996)
  • K961189 — TAS A PTT TEST CONTROLS (June 5, 1996)
  • K960234 — TAS HMT CONTROLS (May 30, 1996)

Other clearances for product code GKP

  • K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP (August 16, 2024)
  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
  • K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP (March 3, 2016)
  • K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP (December 13, 2015)
  • K091980 — ACL TOP 700 LAS (September 22, 2009)
  • K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (May 4, 2008)
  • K063679 — ACL TOP (January 12, 2007)
  • K033414 — ACL TOP MODEL, TOP (January 12, 2004)
  • K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5 (September 8, 2003)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)