Paragon Cze 2000 Capillary Electrophoresis System and BUFFER-100
FDA 510(k) K002799 · Beckman Coulter, Inc.
510(k) numberK002799
Submission
- Device name
- Paragon Cze 2000 Capillary Electrophoresis System and BUFFER-100
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- September 8, 2000
- Decision date
- October 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CFF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | Sebia | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | Sebia | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | Sebia | 05/02/2019SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | Sebia | 01/11/2018SE |
| K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, It/If ControlCFF · Traditional | Sebia | 12/21/2016SE |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGCFF · Special | Sebia | 01/08/2015SE |
| K120169 | Interlab Ife Test Using G 26 Ver. 2.0 InstrumentCFF · Traditional | Grifols USA, LLC | 08/24/2012SE |
| K111369 | The Helena V8 Immunodisplacement KitCFF · Traditional | Helena Laboratories Uk, Ltd. | 06/26/2012SE |
| K103757 | Immunofixation Electrophoresis Test Using Interlab G26 InstrumentCFF · Traditional | Grifols | 10/13/2011SE |
| K082085 | Capillarys Immunotyping, Model 2100CFF · Traditional | Sebia | 04/17/2009SE |
More from Sebia
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Paragon Cze 2000 Capillary Electrophoresis System and BUFFER-100 cleared by the FDA?
Paragon Cze 2000 Capillary Electrophoresis System and BUFFER-100 (K002799) received a 510(k) decision of Substantially Equivalent on October 5, 2000, 27 days after the submission was received.
What is the product code of K002799?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.