The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Atellica Solution, Atellica A-lyte Integrated Multisensor Na+/k+/ci-, Atellica Ch Albumin Bcp Reagent (alb_p), Atellica Im Thyroid Stimulating Hormone Tsh, Atellica Ch Vancomycin (vanc).
| Device ID | K161954 |
| 510k Number | K161954 |
| Device Name: | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Justin Divalentino |
| Correspondent | Justin Divalentino Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CJW |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| Subsequent Product Code | LEH |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2017-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596143 | K161954 | 000 |
| 00630414596136 | K161954 | 000 |
| 00630414002460 | K161954 | 000 |
| 00630414002439 | K161954 | 000 |