The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsysca 15-3 Ii Assay.
| Device ID | K010588 |
| 510k Number | K010588 |
| Device Name: | ELECSYSCA 15-3 II ASSAY |
| Classification | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2001-03-28 |