DFC — Lipoprotein, Low-Density, Antigen, Antiserum, Control Class II
FDA product code DFC covers "Lipoprotein, Low-Density, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5600. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DFC
- Device Class
- Class II
- Regulation Number
- 866.5600
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253069 | diazyme laboratories | Lipoprotein (a) Molarity Assay | June 16, 2026 |
| K241220 | roche diagnostics operations | Tina-quant Lipoprotein(a) Gen.2 Molarity | January 24, 2025 |
| K211058 | sentinel ch | Lp(a) Ultra | December 22, 2022 |
| K180074 | diazyme laboratories | Diazyme Lipoprotein (a) Assay | March 22, 2018 |
| K123046 | siemens healthcare diagnostics | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | December 20, 2012 |
| K122722 | roche diagnostics | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A | November 29, 2012 |
| K082488 | general atomics | DIAZYME LP(A) ASSAY | January 13, 2009 |
| K063838 | thermo electron | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | September 27, 2007 |
| K050487 | biokit | QUANTIA LA(A) | April 26, 2005 |
| K023853 | kamiya biomedical | K-ASSAY LP(A) CONTROLS | December 13, 2002 |
| K021660 | kamiya biomedical | K-ASSAY LP(A) ASSAY | July 25, 2002 |
| K013359 | denka seiken | LP(A)-LATEX SEIKEN ASSAY KIT | March 8, 2002 |
| K013128 | dade behring | N LATEX LP(A) | January 18, 2002 |
| K013206 | roche diagnostics | TINA-QUANT APOLIPOPROTEIN B VER.2 | November 16, 2001 |
| K013207 | roche diagnostics | TINA-QUANT APOLIPOPROTEIN B VER.2 | November 13, 2001 |
| K001931 | wako chemicals usa | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | July 24, 2000 |
| K001934 | wako chemicals usa | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | July 24, 2000 |
| K001929 | wako chemicals usa | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | July 24, 2000 |
| K001933 | wako chemicals usa | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | July 24, 2000 |
| K001920 | wako chemicals usa | WAKO AUTOKIT LP(A)/ RA,500/1000, | July 23, 2000 |