The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Control Kit.
| Device ID | K123725 |
| 510k Number | K123725 |
| Device Name: | FASTPACK CONTROL KIT |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
| Contact | Michael Poirier |
| Correspondent | Michael Poirier Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816467020136 | K123725 | 000 |