The following data is part of a premarket notification filed by Qualisys Diagnostics, Inc. with the FDA for Fastpack Psa Immunoassay, Fastpack System.
| Device ID | K994419 |
| 510k Number | K994419 |
| Device Name: | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | QUALISYS DIAGNOSTICS, INC. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 |
| Contact | Vijay K Mahant |
| Correspondent | Vijay K Mahant QUALISYS DIAGNOSTICS, INC. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-06-28 |
| Summary: | summary |