The following data is part of a premarket notification filed by Diazyme Laboratories Inc. with the FDA for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay.
| Device ID | K211648 |
| 510k Number | K211648 |
| Device Name: | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92064 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-28 |
| Decision Date | 2022-09-08 |