DEH — Lambda, Antigen, Antiserum, Control Class II
FDA product code DEH covers "Lambda, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5550. 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
- DEH
- Device Class
- Class II
- Regulation Number
- 866.5550
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172471 | ventana medical systems | VENTANA CD30 (Ber-H2) RxDx Assay | May 8, 2018 |
| K140396 | binding site group | FREELITE HUMAN LAMBDA FREE KIT | April 16, 2014 |
| K083601 | sentinel ch | LAMBDA LIGHT CHAINS | June 22, 2009 |
| K033811 | binding site | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | January 30, 2004 |
| K031016 | binding site | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETE | July 15, 2003 |
| K023131 | binding site | FREELITE HUMAN LAMBDA FREE KIT | January 21, 2003 |
| K010441 | binding site | FREELITE KAPPA FREE KIT | April 26, 2001 |
| K010440 | binding site | FREELITE LAMBDA FREE KIT | April 26, 2001 |
| K003671 | binding site | LAMBDA IMMAGE FREELITE KIT | February 1, 2001 |
| K002563 | binding site | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | October 26, 2000 |
| K971905 | dako | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON | December 12, 1997 |
| K965022 | dako | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA | November 6, 1997 |
| K940583 | ventana medical systems | VENTANA CD45 PRIMARY ANTIBODY | October 20, 1997 |
| K973393 | ventana medical systems | CHEMMATE LCA | September 25, 1997 |
| K941514 | ventana medical systems | VENTANA ANTI-S100 PRIMARY ANTIBODY | April 25, 1997 |
| K941170 | ventana medical systems | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | April 22, 1997 |
| K941707 | ventana medical systems | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY | April 21, 1997 |
| K941604 | ventana medical systems | VENTANA ANTI-CD4 PRIMARY ANTIBODY | February 14, 1997 |
| K941784 | ventana medical systems | VENTANA ANTI-CD8 PRIMARY ANTIBODY | February 14, 1997 |
| K941516 | ventana medical systems | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY | February 10, 1997 |