The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Testo Immunoassay.
| Device ID | K101388 |
| 510k Number | K101388 |
| Device Name: | FASTPACK TESTO IMMUNOASSAY |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL SUITE B Carlsbad, CA 92011 -1438 |
| Contact | Michael S Poirier |
| Correspondent | Michael S Poirier Qualigen, Inc. 2042 CORTE DEL NOGAL SUITE B Carlsbad, CA 92011 -1438 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2011-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816467020038 | K101388 | 000 |
| 20816467020031 | K101388 | 000 |
| 10816467020034 | K101388 | 000 |