Atlas FDA

LIAISON 25 OH VITAMIN D

FDA 510(k) clearance K032844 · decided 2004-02-12

Clearance details

K-number
K032844
Device name
LIAISON 25 OH VITAMIN D
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2003-09-11
Decision date
2004-02-12
Days to decision
154 days
Clearance type
Traditional
Product code
MRG
Device class
2
Regulation number
862.1825
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Sp recall (Z-1042-2009)Diasorin Inc.2009-03-30
LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, St recall (Z-1240-2008)Diasorin Inc.2008-05-07
LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. recall (Z-0637-05)Diasorin Inc.2005-03-18
Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 recall (Z-0638-05)Diasorin Inc.2005-03-18

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