The following data is part of a premarket notification filed by Bayer Healthcare, Diagnostics Division with the FDA for Advia Chemistry Glucose Oxidase Assay And Advia Chemistry Glucose Hexokinase.
| Device ID | K042015 |
| 510k Number | K042015 |
| Device Name: | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-27 |
| Decision Date | 2004-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595634 | K042015 | 000 |
| 00630414578941 | K042015 | 000 |
| 00630414526720 | K042015 | 000 |