FDA.reportPublic FDA data

510(k) K241220

Device
Tina-quant Lipoprotein(a) Gen.2 Molarity
Applicant
Roche Diagnostics Operations
510(k) number
K241220
Product code
DFC
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-24
Date received
2024-05-01
Regulation
866.5600
Classification name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Leslie Patterson
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DFC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211058Lp(a) UltraSENTINEL CH. SpA2022-12-22
K180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.2018-03-22
K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.2012-12-20
K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics2012-11-29
K082488DIAZYME LP(A) ASSAYGeneral Atomics2009-01-13
K063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHThermo Electron OY2007-09-27
K050487QUANTIA LA(A)Biokit, S.A.2005-04-26
K023853K-ASSAY LP(A) CONTROLSKamiya Biomedical Co.2002-12-13
K021660K-ASSAY LP(A) ASSAYKamiya Biomedical Co.2002-07-25
K013359LP(A)-LATEX SEIKEN ASSAY KITDenka Seiken'S2002-03-08
K013128N LATEX LP(A)Dade Behring, Inc.2002-01-18
K013206TINA-QUANT APOLIPOPROTEIN B VER.2Roche Diagnostics Corp.2001-11-16
K013207TINA-QUANT APOLIPOPROTEIN B VER.2Roche Diagnostics Corp.2001-11-13
K001934WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CXWako Chemicals USA, Inc.2000-07-24
K001933WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIOWako Chemicals USA, Inc.2000-07-24