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510(k) K901075

LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. by London Diagnostics, Inc. — Product Code DBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1990
Date Received
March 8, 1990
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 London Diagnostics, Inc.

  • K914835 — LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY (December 17, 1991)
  • K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY (August 2, 1991)
  • K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (July 30, 1991)
  • K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (February 4, 1991)
  • K904458 — LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION (October 12, 1990)
  • K903130 — LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY (September 25, 1990)
  • K902443 — LUMATAG(TM) LH DIAGNOSTIC KIT (August 2, 1990)
  • K903195 — LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (August 2, 1990)
  • K901484 — LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (May 1, 1990)
  • K881443 — LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (May 27, 1988)

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)
  • K062746 — FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (November 20, 2006)
  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)