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510(k) K801989

NORDICLAB FERRITIN IRMA TEST by Nordiclab Intl. — Product Code DBF

K801989 is an FDA 510(k) premarket notification submitted by Nordiclab Intl. for the device "NORDICLAB FERRITIN IRMA TEST". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Nordiclab Intl. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 19, 1980
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 Nordiclab Intl.

  • K801988 — NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (September 26, 1980)
  • K800921 — NORDICLAB TESTOSTERONE RIA TEST (May 14, 1980)
  • K800920 — NORDICLAB ESTRADIOL RIA TEST (May 14, 1980)
  • K800922 — NORDICLAB PROGESTERONE RIA TEST (May 14, 1980)
  • K792189 — NORDICLAB TOTAL ESTRIOL RIA TEST (November 13, 1979)
  • K782157 — IRMA TEST, NORDICLAB FERRITIN (January 17, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)

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