The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Hcg Immunoassay.
| Device ID | K072264 |
| 510k Number | K072264 |
| Device Name: | FASTPACK HCG IMMUNOASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
| Contact | Michael S Poirier |
| Correspondent | Michael S Poirier Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-15 |
| Decision Date | 2007-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816467020112 | K072264 | 000 |
| 00816467020105 | K072264 | 000 |
| 10816467020126 | K072264 | 000 |