Atlas FDA

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

Chemtron Biotech, Inc. — Predicate Candidate Screening

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

104 daysmedian FDA review time
168 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Chemtron Biotech, Inc.2023-12-201040
K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, ChemtruChemtron Biotech, Inc.2016-04-181670
K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Chemtron Biotech, Inc.2015-04-171200
K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc.2014-12-01770
K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/CupChemtron Biotech, Inc.2014-10-09430
K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTChemtron Biotech, Inc.2013-07-26290
K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CChemtron Biotech, Inc.2013-05-301680
K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TChemtron Biotech, Inc.2012-11-29590
K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TEChemtron Biotech, Inc.2012-05-17140
K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDChemtron Biotech, Inc.2011-09-141260
K102203CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTChemtron Biotech, Inc.2011-01-201690

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