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510(k) K061979

MODIFICATION TO MYALLERGY TEST by Immunetech Corporation — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2006
Date Received
July 13, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Immunetech Corporation

  • K032251 — IMMUNETECH TOTAL IGE SYSTEM (December 19, 2003)
  • K021698 — MY ALLERGY TEST (September 19, 2002)
  • K020387 — MYALLERGYTEST SYSTEM (April 17, 2002)

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