The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Creatinine Plus Ver.2 Assay.
| Device ID | K024098 |
| 510k Number | K024098 |
| Device Name: | COBAS INTEGRA CREATININE PLUS VER.2 ASSAY |
| Classification | Enzymatic Method, Creatinine |
| 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 | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-12 |
| Decision Date | 2002-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121160 | K024098 | 000 |