The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Cystatin C_2 Assay (cysc_2).
| Device ID | K181082 |
| 510k Number | K181082 |
| Device Name: | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) |
| Classification | Test, Cystatin C |
| Applicant | Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, NJ 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, NJ 19714 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-24 |
| Decision Date | 2018-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414236919 | K181082 | 000 |
| 00630414224916 | K181082 | 000 |