The following data is part of a premarket notification filed by Perimmune, Inc. with the FDA for Aura Tek Fdp.
| Device ID | K970353 |
| 510k Number | K970353 |
| Device Name: | AURA TEK FDP |
| Classification | System, Test, Tumor Marker, Monitoring, Bladder |
| Applicant | PERIMMUNE, INC. 1330 PICCARD DR. Rockville, MD 20850 |
| Contact | Sheryl Ruppel |
| Correspondent | Sheryl Ruppel PERIMMUNE, INC. 1330 PICCARD DR. Rockville, MD 20850 |
| Product Code | MMW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-30 |
| Decision Date | 1997-04-30 |
| Summary: | summary |