The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Elecsys Folate Rbc; Roche Elecsys Folate Rbc Calset.
| Device ID | K103716 |
| 510k Number | K103716 |
| Device Name: | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CGN |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-21 |
| Decision Date | 2011-05-12 |
| Summary: | summary |