The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Cholesterol Gen. 2.
| Device ID | K031824 |
| 510k Number | K031824 |
| Device Name: | COBAS INTEGRA CHOLESTEROL GEN. 2 |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121115 | K031824 | 000 |
| 04015630918430 | K031824 | 000 |
| 04015630924967 | K031824 | 000 |
| 04015630922062 | K031824 | 000 |