The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Ca 19-9 Immunoassay, Elecsys Ca 19-9 Calset.
| Device ID | K050231 |
| 510k Number | K050231 |
| Device Name: | ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET |
| Classification | Calibrator, Secondary |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-07-06 |
| Summary: | summary |