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510(k) K791860

FERRITIN RIA KIT by Cis Radiopharmaceuticals, Inc. — Product Code DBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
September 19, 1979
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 Cis Radiopharmaceuticals, Inc.

  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)
  • K792000 — LUTEINIZING HORMONE (LH) RIA (October 30, 1979)
  • K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT (July 24, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K780982 — KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (June 22, 1978)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)
  • K760251 — SET, ORAL ADMINISTRATION (September 15, 1976)

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)