The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas Integra Glucose Hk Gen 3 Assay.
| Device ID | K092603 |
| 510k Number | K092603 |
| Device Name: | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY |
| Classification | Hexokinase, Glucose |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-25 |
| Decision Date | 2009-12-04 |
| Summary: | summary |