The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Glucose Hk Gen. 3 Test System.
| Device ID | K061048 |
| 510k Number | K061048 |
| Device Name: | COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM |
| Classification | Hexokinase, Glucose |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper 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 | 2006-04-17 |
| Decision Date | 2006-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630925025 | K061048 | 000 |
| 04015630920297 | K061048 | 000 |