The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers.
| Device ID | K123983 |
| 510k Number | K123983 |
| Device Name: | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS |
| Classification | System, Test, Vitamin D |
| 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 | MRG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816467020143 | K123983 | 000 |