The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for N Latex Cystatin C; N Protein Standard Uy.
| Device ID | K171072 |
| 510k Number | K171072 |
| Device Name: | N Latex Cystatin C; N Protein Standard UY |
| Classification | Test, Cystatin C |
| Applicant | Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg, DE 35041 |
| Contact | Christine Perkins |
| Correspondent | Christine Perkins Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg, DE 35041 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2017-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414167848 | K171072 | 000 |
| 00630414167824 | K171072 | 000 |