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510(k) K024038

N LATEX IGA by Dade Behring, Inc. — Product Code CZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2003
Date Received
December 6, 2002
Clearance Type
Traditional
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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Other clearances for product code CZP

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  • K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (March 10, 2004)
  • K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (January 14, 2000)
  • 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)