The following data is part of a premarket notification filed by Roche Diagnostics/boehringer Mannheim Gmbh with the FDA for Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay And Elecsys Folate Assay.
| Device ID | K981931 |
| 510k Number | K981931 |
| Device Name: | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 4300 HACIENDA DR. Pleasanton, CA |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 4300 HACIENDA DR. Pleasanton, CA |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-02 |
| Decision Date | 1998-08-25 |
| Summary: | summary |