The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Free T4 Immunoassay.
| Device ID | K030329 |
| 510k Number | K030329 |
| Device Name: | FASTPACK FREE T4 IMMUNOASSAY |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 -1410 |
| Contact | Dorothy Deinzer |
| Correspondent | Dorothy Deinzer Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 -1410 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816467020068 | K030329 | 000 |
| 20816467020055 | K030329 | 000 |