Panels › Immunology › Product code DFC · Class 2
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Regulation 866.5600
1510(k)s in 12 months (43 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in DFC
| Company | 510(k)s | Recalls |
|---|---|---|
| Wako Chemicals USA, Inc. | 9 | 1 |
| DiaSorin, Inc. | 3 | 1 |
| Roche Diagnostics | 4 | 0 |
| Kamiya Biomedical Co. | 2 | 1 |
| Abbott Laboratories | 1 | 1 |
| Diazyme Laboratories, Inc. | 2 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 0 |
| Randox Laboratories, Limited | 0 | 2 |
| Axis Biochemicals, Asa | 1 | 0 |
| Beckman Coulter, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2026 | K253069 | Lipoprotein (a) Molarity Assay Diazyme Laboratories, Inc. | DFC |
| Jan 24, 2025 | K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity Roche Diagnostics Operations | DFC |
| Dec 22, 2022 | K211058 | Lp(a) Ultra SENTINEL CH. SpA, IT | DFC |
| Mar 22, 2018 | K180074 | Diazyme Lipoprotein (a) Assay Diazyme Laboratories, Inc. | DFC |
| Dec 20, 2012 | K123046 | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR Siemens Healthcare Diagnostics, Inc. | DFC |
| Nov 29, 2012 | K122722 | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 Roche Diagnostics | DFC |
| Jan 13, 2009 | K082488 | DIAZYME LP(A) ASSAY General Atomics | DFC |
| Sep 27, 2007 | K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH Thermo Electron OY, FI | DFC |
| Apr 26, 2005 | K050487 | QUANTIA LA(A) Biokit, S.A., ES | DFC |
| Dec 13, 2002 | K023853 | K-ASSAY LP(A) CONTROLS Kamiya Biomedical Co. | DFC |
| Jul 25, 2002 | K021660 | K-ASSAY LP(A) ASSAY Kamiya Biomedical Co. | DFC |
| Mar 8, 2002 | K013359 | LP(A)-LATEX SEIKEN ASSAY KIT Denka Seiken'S, JP | DFC |
| Jan 18, 2002 | K013128 | N LATEX LP(A) Dade Behring, Inc. | DFC |
| Nov 16, 2001 | K013206 | TINA-QUANT APOLIPOPROTEIN B VER.2 Roche Diagnostics Corp. | DFC |
| Nov 13, 2001 | K013207 | TINA-QUANT APOLIPOPROTEIN B VER.2 Roche Diagnostics Corp. | DFC |
| Jul 24, 2000 | K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX Wako Chemicals USA, Inc. | DFC |
| Jul 24, 2000 | K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO Wako Chemicals USA, Inc. | DFC |
| Jul 24, 2000 | K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET Wako Chemicals USA, Inc. | DFC |
| Jul 24, 2000 | K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA Wako Chemicals USA, Inc. | DFC |
| Jul 23, 2000 | K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 Wako Chemicals USA, Inc. | DFC |
| Jul 23, 2000 | K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, Wako Chemicals USA, Inc. | DFC |
| Jul 23, 2000 | K001919 | WAKO AUTOKIT LP(A)/DADE DEMENSION Wako Chemicals USA, Inc. | DFC |
| May 17, 2000 | K000121 | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB Beckman Coulter, Inc. | DFC |
| Apr 25, 2000 | K001118 | MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DiaSorin, Inc. | DFC |
| Dec 21, 1999 | K994110 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET Diasorin/American Standard Companies | DFC |
| Nov 26, 1999 | K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT Trinity Biotech USA | DFC |
| Nov 17, 1999 | K993669 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DiaSorin, Inc. | DFC |
| Apr 14, 1999 | K990595 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B Roche Diagnostics Corp. | DFC |
| Apr 2, 1999 | K982708 | SPQ TEST SYSTEM DiaSorin, Inc. | DFC |
| Mar 9, 1999 | K981446 | WAKO AUTOKIT LP(A) Wako Chemicals USA, Inc. | DFC |
| Jan 26, 1999 | K983281 | APOB Abbott Laboratories | DFC |
| Oct 1, 1998 | K980812 | IMX HOMOCYSTEINE Axis Biochemicals, Asa | DFC |
| Nov 10, 1997 | K970302 | APO-TEK LP(A) Perimmune, Inc. | DFC |
| Dec 20, 1995 | K954657 | WAKO AUTOKIT APO B Wako Chemicals USA, Inc. | DFC |
| Feb 5, 1993 | K923079 | IL TEST CALIBRATION SET APO A1B Instrumentation Laboratory CO | DFC |
| Nov 21, 1990 | K904137 | UC IMU B Eucardio Laboratory, Inc. | DFC |
| Aug 2, 1990 | K903122 | EQUATE(TM) AQR APO AL/B DUO CONTROL Binax, Inc. | DFC |
| Sep 22, 1988 | K883712 | QM300 CONTROL F PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFC |
| Sep 22, 1988 | K883711 | QM300 CALIBRATOR F PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFC |
| Jun 15, 1987 | K872080 | RAICHEM(TM) SPIA(TM) APO B REAGENTS Reagents Applications, Inc. | DFC |
| Aug 14, 1978 | K781015 | ANTI-HUMAN LDL SERUM Icl Scientific | DFC |
| Oct 19, 1977 | K771912 | LAS-R BETA LIPOPROTEIN TEST Hyland Therapeutic Div., Travenol Laboratories | DFC |
| Oct 18, 1977 | K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET Gelman Instrument Co. | DFC |
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