The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To: Cobas Integra Ldl-cholesterol Plus 2nd Generation.
| Device ID | K012287 |
| 510k Number | K012287 |
| Device Name: | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-20 |
| Decision Date | 2001-08-07 |
| Summary: | summary |