The following data is part of a premarket notification filed by Bayer Corp. with the FDA for The Ca 15-3 Assay For The Technicon Immuno 1 System (in Vitro Diagnostic System).
| Device ID | K964703 |
| 510k Number | K964703 |
| Device Name: | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-22 |
| Decision Date | 1997-12-01 |
| Summary: | summary |