510(k) K141689 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
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
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 7, 2015 |
| Received | Jun 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141689
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.