Atlas FDA

LIAISON® Folate

FDA 510(k) clearance K192586 · decided 2020-05-06

Clearance details

K-number
K192586
Device name
LIAISON® Folate
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2019-09-19
Decision date
2020-05-06
Days to decision
230 days
Clearance type
Traditional
Product code
CGN
Device class
2
Regulation number
862.1295
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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
Elecsys Folate III (K233060)Roche Diagnostics2024-06-17
Access Folate Assay (K223590)Beckman Coulter, Inc.2023-08-23
Atellica IM Folate Assay (K172201)Siemens Healthcare Diagnostics, Inc.2018-04-12
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (K161646)Diazyme Laboratories2016-11-04
ELECSYS FOLATE III (K141426)Roche Diagnostics2014-10-17
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (K103716)Roche Diagnostics2011-05-12
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 (K092740)Abbott Laboratories2010-03-05
AIA-PACK RBC FOLATE (K091332)Tosoh Bioscience, Inc.2009-10-02
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340)Roche Diagnostics Corp.2009-06-19
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774)Beckman Coulter, Inc.2006-04-21
ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292)Roche Diagnostics Corp.2005-06-17
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318)Roche Diagnostics Corp.2004-12-23

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