Company ยท US
Qualigen, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2019. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 7 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 3 |
| MRG | System, Test, Vitamin D | 3 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 |
| JIT | Calibrator, Secondary | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2019 | K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay Qualigen, Inc. | CDZ |
| Jan 7, 2015 | K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack H Qualigen, Inc. | DCK |
| Jul 3, 2013 | K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS Qualigen, Inc. | MRG |
| Mar 8, 2013 | K123725 | FASTPACK CONTROL KIT Qualigen, Inc. | JJY |
| Feb 18, 2011 | K101388 | FASTPACK TESTO IMMUNOASSAY Qualigen, Inc. | CDZ |
| Aug 13, 2010 | K101390 | FASTPACK TSH IMMUNOASSAY Qualigen, Inc. | JLW |
| Dec 6, 2007 | K072264 | FASTPACK HCG IMMUNOASSAY Qualigen, Inc. | JHI |
| Apr 2, 2007 | K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT Qualigen, Inc. | JJX |
| Jan 4, 2006 | K052301 | FASTPACK TSH IMMUNOASSAY Qualigen, Inc. | JLW |
| Jul 3, 2003 | K030329 | FASTPACK FREE T4 IMMUNOASSAY Qualigen, Inc. | CEC |
| Sep 30, 2002 | K022533 | FASTPACK TESTOSTERONE CALIBRATOR Qualigen, Inc. | JIT |
| Aug 21, 2002 | K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY Qualigen, Inc. | CDZ |
| Nov 30, 2000 | K003096 | FASTPACK CALIBRATORS Qualigen, Inc. | JIT |
| Nov 29, 2000 | K003095 | FASTPACK CONTROL Qualigen, Inc. | JJX |
| Oct 25, 2000 | K003094 | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER Qualigen, Inc. | LTJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2025 | Qualigen Inc The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks. Open, Classified |
CDZ | K182521 |
| Oct 8, 2024 | Qualigen Inc FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer Open, Classified |
JLW | K052301 |
| Nov 6, 2019 | Qualigen Inc The FastPack System Comlete Immunoassay Kit
Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding G Terminated |
CDZ | K182521 |
| Jul 7, 2017 | Qualigen Inc Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068
Vitamin D immunoassay kit Terminated |
MRG | K123983 |
| Dec 19, 2013 | Qualigen Inc FastPack Free T4 Immunoassay
FastPack Vitamin D Immunoassay
Chemilunescence assay for the determination of Vitamin D
The FastPack Vitamin D Immunoassay is intended for the quantitative determinatio Terminated |
MRG | K123983 |
| Dec 19, 2013 | Qualigen Inc FastPack Free T4 Immunoassay
Chemilunescence assay for the determination of Free T4
The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determinati Terminated |
CEC | K030329 |
| Dec 19, 2013 | Qualigen Inc FastPack Testosterone Immunoassay
Chemilunescence assay for the determination of Testosterone
The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative dete Terminated |
CDZ | K021972 |
| Dec 19, 2013 | Qualigen Inc FastPack Total PSA Immunoassay
Chemilunescence assay for the determination of Total PSA.
FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determina Terminated |
LTJ | K994419 |
| Dec 22, 2008 | Qualigen Inc FastPack(R) Total PSA Immunoassay; Catalog #: 25000001
Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma Terminated |
LTJ | K994419 |
| Nov 6, 2003 | Qualigen Inc Device to determine quantitative total testosterone in human serum Terminated |
CDZ | None listed |