The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Elecsys Folate Ii Assay.
| Device ID | K031756 |
| 510k Number | K031756 |
| Device Name: | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY |
| Classification | Acid, Folic, Radioimmunoassay |
| 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 | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-06 |
| Decision Date | 2003-06-25 |
| Summary: | summary |