The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Alp Ifcc Gen.2.
| Device ID | K033185 |
| 510k Number | K033185 |
| Device Name: | COBAS INTEGRA ALP IFCC GEN.2 |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2003-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336120972 | K033185 | 000 |