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510(k) K883746

MICROMEDIC FERRITIN IRMA KIT by Icn Micromedic Systems — Product Code DBF

K883746 is an FDA 510(k) premarket notification submitted by Icn Micromedic Systems for the device "MICROMEDIC FERRITIN IRMA KIT". The FDA issued a decision of Substantially Equivalent on October 27, 1988. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Icn Micromedic Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1988
Date Received
September 1, 1988
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 Icn Micromedic Systems

  • K884269 — SAMPLE IDENTIFICATION STATION MODEL 38010 (January 9, 1989)
  • K880674 — MICROMEDIC CRACKPOT RIA KIT (October 6, 1988)
  • K881102 — MICROMEDIC MORPHINE RIA KIT (June 24, 1988)

Other clearances for product code DBF

  • K193650 — LIAISON Ferritin (September 14, 2021)
  • 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)
  • K062746 — FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (November 20, 2006)
  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)

FDA data resources