FDA 510(k) Applications Submitted by MICHAEL S POIRIER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K141689 |
06/23/2014 |
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 |
Qualigen, Inc. |
| K032425 |
08/06/2003 |
INVISIJECT RESUSABLE AUTO-INJECTOR |
BIOGEN |
| K123725 |
12/04/2012 |
FASTPACK CONTROL KIT |
Qualigen, Inc. |
| K101388 |
05/17/2010 |
FASTPACK TESTO IMMUNOASSAY |
Qualigen, Inc. |
| K101390 |
05/17/2010 |
FASTPACK TSH IMMUNOASSAY |
Qualigen, Inc. |
| K072264 |
08/15/2007 |
FASTPACK HCG IMMUNOASSAY |
Qualigen, Inc. |
| K123983 |
12/26/2012 |
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS |
Qualigen, Inc. |
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