The following data is part of a premarket notification filed by Qualisys Diagnostics, Inc. with the FDA for Qualisys Psa Immunoassay.
| Device ID | K990234 |
| 510k Number | K990234 |
| Device Name: | QUALISYS PSA IMMUNOASSAY |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | QUALISYS DIAGNOSTICS, INC. 16 TECHNOLOGY DR., SUITE 118 Irvine, CA 92618 |
| Contact | Grace Kwan |
| Correspondent | Grace Kwan QUALISYS DIAGNOSTICS, INC. 16 TECHNOLOGY DR., SUITE 118 Irvine, CA 92618 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-07-08 |
| Summary: | summary |