The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Ims Lithium Assay.
| Device ID | K050374 |
| 510k Number | K050374 |
| Device Name: | ADVIA IMS LITHIUM ASSAY |
| Classification | Assay, Porphyrin, Spectrophotometry, Lithium |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | NDW |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-14 |
| Decision Date | 2005-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414509778 | K050374 | 000 |
| 00630414223414 | K050374 | 000 |
| 00630414006789 | K050374 | 000 |
| 05055273209143 | K050374 | 000 |
| 00630414288178 | K050374 | 000 |
| 00630414287935 | K050374 | 000 |