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510(k) K913670

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT by The Binding Site, Ltd. — Product Code DAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
August 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Haptoglobin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5460
Review Panel
IM
Submission Type

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  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

Other clearances for product code DAB

  • K843570 — FIAX HAPTOGLOBIN TEST KIT (October 5, 1984)
  • K772078 — RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (February 3, 1978)