The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for C.f.a.s. Proteins, C.f.a.s. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein.
| Device ID | K133330 |
| 510k Number | K133330 |
| Device Name: | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | Roche Diagnostics 9115 SOUTH HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck Roche Diagnostics 9115 SOUTH HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-01 |
| Decision Date | 2013-11-26 |
| Summary: | summary |