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510(k) K020387

MYALLERGYTEST SYSTEM by Immunetech Corporation — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
February 5, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Immunetech Corporation

  • K061979 — MODIFICATION TO MYALLERGY TEST (September 22, 2006)
  • K032251 — IMMUNETECH TOTAL IGE SYSTEM (December 19, 2003)
  • K021698 — MY ALLERGY TEST (September 19, 2002)

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