The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Total Prostate Specific Antigen (tpsa), Model 30 428.
| Device ID | K010550 |
| 510k Number | K010550 |
| Device Name: | VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nancy Weaver |
| Correspondent | Nancy Weaver BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-04-24 |