Qualigen, Inc. is one of 13040 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Qualigen, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FastPack IP Sex Hormone Binding Globulin Immunoassay, 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, FASTPACK VITAMIN D
15
Total
15
Cleared
0
Denied
Qualigen, Inc. has 15 FDA 510(k) cleared chemistry devices. Based in Carlsbad, US.
Historical record: 15 cleared submissions from 2000 to 2019.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Qualigen, Inc.
15 devices
Cleared
Jan 29, 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
Chemistry
138d
Cleared
Jan 07, 2015
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity...
Chemistry
198d
Cleared
Jul 03, 2013
FASTPACK VITAMIN D
Chemistry
189d
Cleared
Mar 08, 2013
FASTPACK CONTROL KIT
Chemistry
94d
Cleared
Feb 18, 2011
FASTPACK TESTO IMMUNOASSAY
Chemistry
277d
Cleared
Aug 13, 2010
FASTPACK TSH IMMUNOASSAY
Chemistry
88d
Cleared
Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
Chemistry
113d
Cleared
Apr 02, 2007
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
Immunology
185d
Cleared
Jan 04, 2006
FASTPACK TSH IMMUNOASSAY
Chemistry
135d
Cleared
Jul 03, 2003
FASTPACK FREE T4 IMMUNOASSAY
Chemistry
153d
Cleared
Sep 30, 2002
FASTPACK TESTOSTERONE CALIBRATOR
Chemistry
61d
Cleared
Aug 21, 2002
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
Chemistry
65d
Cleared
Nov 30, 2000
FASTPACK CALIBRATORS
Immunology
58d
Cleared
Nov 29, 2000
FASTPACK CONTROL
Immunology
57d
Cleared
Oct 25, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
Immunology
22d