The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Advia: Centaur And Acs: 180 Cpsa Assay.
| Device ID | K002376 |
| 510k Number | K002376 |
| Device Name: | ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | William J Pignato |
| Correspondent | William J Pignato BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-10-26 |