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510(k) K060130

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT by Beckman Coulter, Inc. — Product Code CZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2006
Date Received
January 18, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K983359 — IGA (November 4, 1998)
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  • K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K955907 — BOEHRINGER MANNHEIM IGA ASSAY (February 9, 1996)
  • K952309 — N LATEX IGA (June 20, 1995)
  • K931806 — IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (July 16, 1993)