The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Ca 15-3 Test System.
| Device ID | K001468 |
| 510k Number | K001468 |
| Device Name: | ELECSYS CA 15-3 TEST SYSTEM |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-10 |
| Decision Date | 2000-10-23 |