The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Tsh Immunoassay.
| Device ID | K052301 |
| 510k Number | K052301 |
| Device Name: | FASTPACK TSH IMMUNOASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
| Contact | Dorothy Peterson |
| Correspondent | Dorothy Peterson Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
| Product Code | JLW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-22 |
| Decision Date | 2006-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816467020099 | K052301 | 000 |