The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack High Sensitivity C-reactive Protein Immunoassay, High Sensitivity C-reactive Protein Calibrator Kit, Fastpack High Sensitivity C-reactive Protein Controls, Fastpack High Sensitivity C-reactive Protein Method Verification Kit.
| Device ID | K141689 |
| 510k Number | K141689 |
| Device Name: | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| 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 | DCK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2015-01-07 |
| Summary: | summary |