The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Cobas Integra Albumin Gen. 2.
| Device ID | K033009 |
| 510k Number | K033009 |
| Device Name: | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 |
| Classification | Bromcresol Green Dye-binding, Albumin |
| 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 | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2003-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336120958 | K033009 | 000 |
| 07613336120941 | K033009 | 000 |
| 04015630911509 | K033009 | 000 |
| 04015630924820 | K033009 | 000 |
| 04015630922581 | K033009 | 000 |
| 04015630918898 | K033009 | 000 |
| 04015630911523 | K033009 | 000 |
| 04015630911516 | K033009 | 000 |