The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Advia 1650 Glucose Hexokinase 11 Assay.
| Device ID | K011963 |
| 510k Number | K011963 |
| Device Name: | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY |
| Classification | Hexokinase, Glucose |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-22 |
| Decision Date | 2001-11-20 |
| Summary: | summary |