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

Toxi-Lab, Inc. — Predicate Candidate Screening

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

141 daysmedian FDA review time
233 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932209TOXI*LAB LTD OPIATE SYSTEMToxi-Lab, Inc.1993-09-241410
K923337ON*SITE ALCOHOLToxi-Lab, Inc.1993-01-122080
K903223ON-SITE ALCOHOLToxi-Lab, Inc.1991-03-132330
K901694SPEC(TM) EXTRACTION CARTRIDGEToxi-Lab, Inc.1990-06-01520
K900626ALPHA URINE SAMPLEToxi-Lab, Inc.1990-03-06260

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