The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Elecsys Afp Calset Ii.
| Device ID | K043095 |
| 510k Number | K043095 |
| Device Name: | ROCHE DIAGNOSTICS ELECSYS AFP CALSET II |
| Classification | Calibrator, Secondary |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2004-11-23 |
| Summary: | summary |