Home / 510(k) Clearances / K993519

510(k) K993519

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST by Cardiovascular Diagnostics, Inc. — Product Code JOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 14, 2000
Date Received: October 18, 1999
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Analyzer, Heparin, Automated
Device Class: Class II
Regulation Number: 864.5680
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)
K990566 — TAS ANALYZER, MODEL 1009 (May 14, 1999)
K981206 — TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) (May 26, 1998)
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 JOX

K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (June 8, 2011)
K102953 — HEPARIN DOSE RESPONSE CARTRIDGE (November 4, 2010)
K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (October 13, 2010)
K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)
K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (December 3, 2004)
K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (October 1, 2004)
K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)
K911240 — HEPCON HMS WITH BODY SURFACE AREA CALCULATION (July 17, 1991)
K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (September 5, 1989)
K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)