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Qualigen, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K182521 FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ2019-01-29 View
510(k) K123983 FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSMRG2013-07-03 View
510(k) K123725 FASTPACK CONTROL KITJJY2013-03-08 View
510(k) K101388 FASTPACK TESTO IMMUNOASSAYCDZ2011-02-18 View
510(k) K101390 FASTPACK TSH IMMUNOASSAYJLW2010-08-13 View
510(k) K072264 FASTPACK HCG IMMUNOASSAYJHI2007-12-06 View
510(k) K062957 FASTPACK TOTAL PSA METHOD VERIFICATION KITJJX2007-04-02 View
510(k) K052301 FASTPACK TSH IMMUNOASSAYJLW2006-01-04 View
510(k) K030329 FASTPACK FREE T4 IMMUNOASSAYCEC2003-07-03 View
510(k) K022533 FASTPACK TESTOSTERONE CALIBRATORJIT2002-09-30 View
510(k) K021972 FASTPACK TOTAL TESTOSTERONE IMMUNOASSAYCDZ2002-08-21 View
510(k) K003096 FASTPACK CALIBRATORSJIT2000-11-30 View
510(k) K003095 FASTPACK CONTROLJJX2000-11-29 View
510(k) K003094 FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZERLTJ2000-10-25 View
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