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510(k) K042941

DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS by Dade Behring, Inc. — Product Code GIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2004
Date Received
October 25, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Control, Normal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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Other clearances for product code GIZ

  • K060968 — STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; (May 15, 2007)
  • K023309 — CONTROL PLASMA N (November 1, 2002)
  • K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10 (December 10, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)
  • K001256 — CONTROL PLASMA N (May 24, 2000)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089) (October 31, 1997)
  • K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (August 13, 1996)
  • K941737 — SPECIALTY ASSAYED CONTROL-1 (October 7, 1994)
  • K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (September 19, 1994)