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 |