The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Atellica Ch Creatinine_2 (crea_2), Atellica Ch Chemistry Calibrator (chem Cal).
| Device ID | K161494 |
| 510k Number | K161494 |
| Device Name: | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, PO Box 6101 MS 514 Newark, DE 19711 |
| Contact | Laura J. Duggan |
| Correspondent | Laura J. Duggan Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, PO Box 6101 MS 514 Newark, DE 19711 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597492 | K161494 | 000 |
| 00630414596457 | K161494 | 000 |