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510(k) K900422

TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 by Helena Laboratories — Product Code CZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1990
Date Received
January 30, 1990
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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  • K983359 — IGA (November 4, 1998)
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  • K955907 — BOEHRINGER MANNHEIM IGA ASSAY (February 9, 1996)
  • K952309 — N LATEX IGA (June 20, 1995)