Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Qualigen, Inc. — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

113 daysmedian FDA review time
198 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc.2019-01-291381
K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, HiQualigen, Inc.2015-01-071980
K123983FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIQualigen, Inc.2013-07-031891
K123725FASTPACK CONTROL KITQualigen, Inc.2013-03-08940
K101388FASTPACK TESTO IMMUNOASSAYQualigen, Inc.2011-02-182770
K101390FASTPACK TSH IMMUNOASSAYQualigen, Inc.2010-08-13880
K072264FASTPACK HCG IMMUNOASSAYQualigen, Inc.2007-12-061130
K062957FASTPACK TOTAL PSA METHOD VERIFICATION KITQualigen, Inc.2007-04-021850
K052301FASTPACK TSH IMMUNOASSAYQualigen, Inc.2006-01-041351
K030329FASTPACK FREE T4 IMMUNOASSAYQualigen, Inc.2003-07-031531
K022533FASTPACK TESTOSTERONE CALIBRATORQualigen, Inc.2002-09-30610
K021972FASTPACK TOTAL TESTOSTERONE IMMUNOASSAYQualigen, Inc.2002-08-21651
K003096FASTPACK CALIBRATORSQualigen, Inc.2000-11-30580
K003095FASTPACK CONTROLQualigen, Inc.2000-11-29570
K003094FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZERQualigen, Inc.2000-10-25220

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda