Atlas FDA

LIAISON Ferritin

FDA 510(k) clearance K193650 · decided 2021-09-14

Clearance details

K-number
K193650
Device name
LIAISON Ferritin
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2019-12-30
Decision date
2021-09-14
Days to decision
624 days
Clearance type
Traditional
Product code
DBF
Device class
2
Regulation number
866.5340
Medical specialty
Immunology
Advisory committee
Immunology
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562)HORIBA ABX SAS2020-03-06
Atellica IM Ferritin Assay (K171642)Siemens Healthcare Diagnostics, Inc.2017-08-31
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET (K133083)Diazyme Laboratories2014-06-24
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (K121232)Kamiya Biomedical Company2012-05-24
ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736)Siemens Healthcare Diagnostics, Inc.2011-08-17
TINA-QUANT FERRITIN GEN. 4 (K100538)Roche Diagnostics2010-06-22
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505)Beckman Coulter, Inc.2009-12-11
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746)Medicon Hellas S.A2006-11-20
RDI HSFERRITIN KIT (K053211)Reference Diagnostics, Inc.2006-03-13
FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, (K052617)Good Biotech Corp.2006-02-23
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944)Kamiya Biomedical Co.2005-12-23
QUANTEX FERRITIN (K040879)Instrumentation Laboratory CO2004-05-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008)DiaSorin, Inc.2025-12-19
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041)DiaSorin, Inc.2025-12-19
LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021)DiaSorin, Inc.2025-10-10
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020)DiaSorin, Inc.2025-10-10
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021)DiaSorin, Inc.2025-10-10