The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Ims Glucose Assay.
| Device ID | K052163 |
| 510k Number | K052163 |
| Device Name: | ADVIA IMS GLUCOSE ASSAY |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2005-10-11 |
| Summary: | summary |