FDA Product Code
FDA Product Code CFF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203184 | HYDRASHIFT 2/4 isatuximab | Sebia | 2021-11-12 | Traditional | PDF ↗ |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | 2019-11-01 | Traditional | PDF ↗ |
| K190851 | HYDRASHIFT 2/4 daratumumab | Sebia | 2019-05-02 | Special | PDF ↗ |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Sebia | 2018-01-11 | Traditional | PDF ↗ |
| K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | Sebia | 2016-12-21 | Traditional | PDF ↗ |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia | 2015-01-08 | Special | PDF ↗ |
| K120169 | INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT | Grifols USA, LLC | 2012-08-24 | Traditional | PDF ↗ |
| K111369 | THE HELENA V8 IMMUNODISPLACEMENT KIT | Helena Laboratories Uk, Ltd. | 2012-06-26 | Traditional | PDF ↗ |
| K103757 | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT | Grifols | 2011-10-13 | Traditional | PDF ↗ |
| K082085 | CAPILLARYS IMMUNOTYPING, MODEL 2100 | Sebia | 2009-04-17 | Traditional | PDF ↗ |
| K082388 | MINICAP IMMUNOTYPING, MODEL: 2300 | Sebia | 2009-04-14 | Traditional | PDF ↗ |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | Helena Laboratories | 2006-07-06 | Traditional | PDF ↗ |
| K033187 | INTERLAB IMMUNOFIXATION TEST(S) | Interlab S.R.L. | 2003-11-19 | Traditional | PDF ↗ |
| K033277 | HYDRAGEL CSF ISOFOCUSING KITS | Morax | 2003-11-04 | Special | PDF ↗ |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Helena Laboratories | 2003-02-19 | Traditional | PDF ↗ |
| K002799 | PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 | Beckman Coulter, Inc. | 2000-10-05 | Special | PDF ↗ |
| K993323 | K-ASSAY IGM | Kamiya Biomedical Co. | 1999-11-30 | Traditional | PDF ↗ |
| K993213 | K-ASSAY IGA | Kamiya Biomedical Co. | 1999-11-23 | Traditional | PDF ↗ |
| K990998 | POLYSLIT IFE KIT | Helena Laboratories | 1999-06-28 | Traditional | PDF ↗ |
| K981048 | HYDRAGEL 6 CSF KIT | Morax | 1998-10-07 | Traditional | PDF ↗ |
| K973040 | SPIFE IFE-6 | Helena Laboratories | 1998-01-02 | Traditional | PDF ↗ |
| K960669 | HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS | Morax | 1996-07-12 | Traditional | PDF ↗ |
| K933972 | N-ASSAY TIA IGG | Crestat Diagnostics, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K924769 | IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC | The Binding Site, Ltd. | 1993-02-23 | Traditional | PDF ↗ |
| K924767 | IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC | The Binding Site, Ltd. | 1993-02-23 | Traditional | PDF ↗ |
| K923658 | REP IMMUNOFIX | Helena Laboratories | 1992-11-02 | Traditional | PDF ↗ |
| K892424 | REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 | Helena Laboratories | 1989-06-09 | Traditional | PDF ↗ |
| K823884 | PARAGON IMMUNOELECTROPHORESIS REAGENT | Beckman Instruments, Inc. | 1983-03-07 | Traditional | PDF ↗ |
| K790667 | CORNING PARAPROTEIN SCREENING | Corning Medical & Scientific | 1979-07-24 | Traditional | PDF ↗ |
Product code CFF · Class II · Immunology. Data: openFDA.