Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Omega Laboratories, Inc. · Predicate Candidate Screening

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

204 daysmedian FDA review time
412 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142855Omega Laboratories Hair Drug Screening Assay MethamphetamineOmega Laboratories, Inc.2015-07-283010
K140671OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXOmega Laboratories, Inc.2015-01-082960
K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE ANDOmega Laboratories, Inc.2013-11-132040
K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.2013-06-25610
K122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THOmega Laboratories, Inc.2012-12-05860
K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE ANDOmega Laboratories, Inc.2012-01-231180
K103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATESOmega Laboratories, Inc.2011-12-134120
K101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAOmega Laboratories, Inc.2011-08-163990
K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDIOmega Laboratories, Inc.2010-07-12880

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