The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Elecsys Folate Iii, Roche Elecsys Rbc Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys.
| Device ID | K082340 |
| 510k Number | K082340 |
| Device Name: | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CGN |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-15 |
| Decision Date | 2009-06-19 |
| Summary: | summary |