The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Glucose Hk New Formulation Test System.
| Device ID | K062239 |
| 510k Number | K062239 |
| Device Name: | GLUCOSE HK NEW FORMULATION TEST SYSTEM |
| Classification | Hexokinase, Glucose |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa Ambrose Bush |
| Correspondent | Theresa Ambrose Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. 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 | 2006-08-02 |
| Decision Date | 2006-09-11 |
| Summary: | summary |