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510(k) K843710

ELISA FOR TOTAL IGE by Scientific Research — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1984
Date Received
September 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Scientific Research

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  • K843077 — ELISA FOR HERPES SIMPLEX VIRUS (June 21, 1985)
  • K842887 — HERPES VIRUS AGGLUTINATION TEST (February 26, 1985)
  • K843369 — AGGLUTINATION TEST FOR TOTAL IGE (November 14, 1984)

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