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 | K181438 |
| 510k Number | K181438 |
| 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 92130 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92130 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-06-26 |