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LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device

FDA 510(k) clearance K182698 · decided 2018-12-26

Clearance details

K-number
K182698
Device name
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2018-09-27
Decision date
2018-12-26
Days to decision
90 days
Clearance type
Traditional
Product code
NXO
Device class
2
Regulation number
866.5180
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
BÜHLMANN fCAL® turbo and CALEX® Cap (K232057)Bühlmann Laboratories AG2024-02-06
ALPCO Calprotectin Immunoturbidimetric Assay (K220763)ALPCO2023-04-13
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858)DiaSorin, Inc.2022-07-26
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device (K191807)ALPCO2019-10-25
Buhlmann fCAL turbo and CALEX Cap (K191718)Buhlmann Laboratories AG2019-09-24
Calprest, EasyCal (K191589)Eurospital S.P.A.2019-07-10
CalprestNG, EasyCal (K191592)Eurospital S.P.A.2019-07-10
BUHLMANN fCAL turbo (K190784)Buhlmann Laboratories AG2019-06-25
QUANTA Flash Calprotectin and Fecal Extraction Device (K180971)Inova Diagnostics, Inc.2018-10-16
BUHLMANN fCAL ELISA (K181012)Buhlmann Laboratories AG2018-06-04
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer (K170993)Inova Diagnostics, Inc.2017-12-22
Calprest NG (K160447)Eurospital S.P.A.2016-11-10

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