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510(k) K983880

TRANSFERRIN SPQ III ANTIBODY REAGENT SET by DiaSorin, Inc. — Product Code DDG

K983880 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "TRANSFERRIN SPQ III ANTIBODY REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 18, 1998. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1998
Date Received
November 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

Other clearances by DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)

Other clearances for product code DDG

  • K240987 — Access sTfR (July 3, 2024)
  • K190495 — Transferrin (March 16, 2020)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (November 5, 2018)
  • K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS (February 13, 2013)
  • K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A3 (August 11, 2008)
  • K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (August 8, 2008)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (August 8, 2007)
  • K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (April 23, 2007)
  • K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (March 21, 2007)
  • K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTR (January 24, 2007)

FDA data resources