The following data is part of a premarket notification filed by Bayer Corp. with the FDA for The Complexed Psa Assay For The Bayer Immuno 1 System.
| Device ID | K980376 |
| 510k Number | K980376 |
| Device Name: | THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| 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 | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-04-23 |
| Summary: | summary |