The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Ch Enzymatic Creatinine_3 (ecre3).
| Device ID | K212223 |
| 510k Number | K212223 |
| Device Name: | Atellica CH Enzymatic Creatinine_3 (ECre3) |
| Classification | Enzymatic Method, Creatinine |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Ian Thompson |
| Correspondent | Ian Thompson Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414301587 | K212223 | 000 |