The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Pegasys Ultra.
| Device ID | K993946 |
| 510k Number | K993946 |
| Device Name: | PEGASYS ULTRA |
| Classification | System, Image Processing, Radiological |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Janice Brown |
| Correspondent | Janice Brown ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-19 |
| Decision Date | 2000-03-09 |
| Summary: | summary |