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510(k) K001256

CONTROL PLASMA N by Dade Behring, Inc. — Product Code GIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2000
Date Received
April 19, 2000
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

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  • K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10 (December 10, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)
  • 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)