The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for N Latex Flc Kappa, N Latex Flc Lambda.
| Device ID | K193047 |
| 510k Number | K193047 |
| Device Name: | N Latex FLC Kappa, N Latex FLC Lambda |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg, DE 35041 |
| Contact | Christine Perkins |
| Correspondent | Sanja Matern Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg, DE 35041 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2021-07-14 |