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510(k) K843369

AGGLUTINATION TEST FOR TOTAL IGE by Scientific Research — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1984
Date Received
August 28, 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

  • K912420 — ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM (September 23, 1991)
  • K843077 — ELISA FOR HERPES SIMPLEX VIRUS (June 21, 1985)
  • K842887 — HERPES VIRUS AGGLUTINATION TEST (February 26, 1985)
  • K843710 — ELISA FOR TOTAL IGE (October 22, 1984)

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