Paragon Immunoelectrophoresis Reagent
FDA 510(k) K823884 · Beckman Instruments, Inc.
510(k) numberK823884
Submission
- Device name
- Paragon Immunoelectrophoresis Reagent
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- December 27, 1982
- Decision date
- March 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Paragon Immunoelectrophoresis Reagent cleared by the FDA?
Paragon Immunoelectrophoresis Reagent (K823884) received a 510(k) decision of Substantially Equivalent on March 7, 1983, 70 days after the submission was received.
What is the product code of K823884?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.