Atlas FDA

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

Ameditech, Inc. — Predicate Candidate Screening

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

79 daysmedian FDA review time
133 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)Ameditech, Inc.2011-12-05100
K113046AMEDITECH IMMUTEST MILTI-DRUG SCREENAmeditech, Inc.2011-11-10283
K063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150Ameditech, Inc.2006-12-20792
K053175AMEDITECH DRUGSMARTCUPAmeditech, Inc.2005-12-08242
K050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIAmeditech, Inc.2005-03-04363
K042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIAmeditech, Inc.2004-12-29623
K040092AMEDITECH IMMU TEST DRUG SCREEN PANELAmeditech, Inc.2004-03-08520
K023126AMEDITECH IMMUTEST HCG PREGANCY TESTAmeditech, Inc.2002-11-18600
K012484AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINEAmeditech, Inc.2001-11-301200
K012483AMEDITECH IMMUTEST DRUG SCREEN OPIATESAmeditech, Inc.2001-11-301200
K012582AMEDITECH IMMUTEST DRUG SCREEN PCPAmeditech, Inc.2001-11-301120
K012585AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINEAmeditech, Inc.2001-11-16980
K011813AMEDITECH IMMUTEST DRUG SCREEN THCAmeditech, Inc.2001-10-221330
K011814AMEDITECH IMMUTEST DRUG SCREEN COCAmeditech, Inc.2001-10-221330

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