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510(k) K062746

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 by Medicon Hellas S.A — Product Code DBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2006
Date Received
September 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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Other clearances for product code DBF

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  • K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Fact (March 6, 2020)
  • K171642 — Atellica IM Ferritin Assay (August 31, 2017)
  • K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTRO (June 24, 2014)
  • K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (May 24, 2012)
  • K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD (August 17, 2011)
  • K100538 — TINA-QUANT FERRITIN GEN. 4 (June 22, 2010)
  • K092505 — BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (December 11, 2009)
  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)
  • K052617 — FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; (February 23, 2006)