FDA 510(k) Applications Submitted by Qualigen, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K030329 |
01/31/2003 |
FASTPACK FREE T4 IMMUNOASSAY |
Qualigen, Inc. |
| K021972 |
06/17/2002 |
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY |
Qualigen, Inc. |
| K022533 |
07/31/2002 |
FASTPACK TESTOSTERONE CALIBRATOR |
Qualigen, Inc. |
| K003094 |
10/03/2000 |
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER |
Qualigen, Inc. |
| K003095 |
10/03/2000 |
FASTPACK CONTROL |
Qualigen, Inc. |
| K003096 |
10/03/2000 |
FASTPACK CALIBRATORS |
Qualigen, Inc. |
| K052301 |
08/22/2005 |
FASTPACK TSH IMMUNOASSAY |
Qualigen, Inc. |
| K062957 |
09/29/2006 |
FASTPACK TOTAL PSA METHOD VERIFICATION KIT |
Qualigen, Inc. |
| 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. |
| 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. |
| K182521 |
09/13/2018 |
FastPack IP Sex Hormone Binding Globulin Immunoassay |
Qualigen, Inc. |
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