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510(k) K920014

IL TEST IMMUNOGLOBULIN A by Instrumentation Laboratory CO — Product Code CZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1992
Date Received
January 2, 1992
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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  • K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (January 14, 2000)
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  • K955907 — BOEHRINGER MANNHEIM IGA ASSAY (February 9, 1996)
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