Qualigen, Inc. - FDA 510(k) Cleared Devices

Cleared Jan 29, 2019

FastPack IP Sex Hormone Binding Globulin Immunoassay

K182521 · CDZ

Chemistry · 138d

Cleared Jan 07, 2015

FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity...

K141689 · DCK

Chemistry · 198d

Cleared Jul 03, 2013

FASTPACK VITAMIN D

K123983 · MRG

Chemistry · 189d

Cleared Mar 08, 2013

FASTPACK CONTROL KIT

K123725 · JJY

Chemistry · 94d

Cleared Feb 18, 2011

FASTPACK TESTO IMMUNOASSAY

K101388 · CDZ

Chemistry · 277d

Cleared Aug 13, 2010

FASTPACK TSH IMMUNOASSAY

K101390 · JLW

Chemistry · 88d

Cleared Dec 06, 2007

FASTPACK HCG IMMUNOASSAY

K072264 · JHI

Chemistry · 113d

Cleared Jan 04, 2006

FASTPACK TSH IMMUNOASSAY

K052301 · JLW

Chemistry · 135d

Cleared Jul 03, 2003

FASTPACK FREE T4 IMMUNOASSAY

K030329 · CEC

Chemistry · 153d

Cleared Sep 30, 2002

FASTPACK TESTOSTERONE CALIBRATOR

K022533 · JIT

Chemistry · 61d

Cleared Aug 21, 2002

FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY

K021972 · CDZ

Chemistry · 65d