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510(k) K974505

AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 by Alfa Biotech (Uk) , Ltd. — Product Code DBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1998
Date Received
December 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5340
Review Panel
IM
Submission Type

Other clearances by Alfa Biotech (Uk) , Ltd.

  • K980574 — AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK (March 24, 1998)
  • K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (February 2, 1998)

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  • K092505 — BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (December 11, 2009)
  • K062746 — FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (November 20, 2006)
  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)