The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Psa Immunoassay, Fastpack Analyzer.
| Device ID | K003094 |
| 510k Number | K003094 |
| Device Name: | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 |
| Contact | Dorothy Deinzer |
| Correspondent | Dorothy Deinzer Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816467020014 | K003094 | 000 |
| 20816467020017 | K003094 | 000 |
| 10816467020010 | K003094 | 000 |