Atlas FDA

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

Scimedx Corp. · Predicate Candidate Screening

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

57 daysmedian FDA review time
203 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011348PHASE II GBM IGG ANTIBODY EIA TESTScimedx Corp.2001-06-25540
K011082TPO IGG ANTIBODY EIA TESTScimedx Corp.2001-06-06570
K010625EUROSPITAL EU-TTG IGA UMANAScimedx Corp.2001-04-24530
K010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAScimedx Corp.2001-03-16440
K010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAScimedx Corp.2001-03-07350
K002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEMScimedx Corp.2000-10-19930
K002189GLIADIN IGG ANTIBODY EIA DETECTION SYSTEMScimedx Corp.2000-10-19920
K002107IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING Scimedx Corp.2000-08-04230
K994379EU-TTG IGA ELISAScimedx Corp.2000-02-18530
K970198IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIESScimedx Corp.1997-02-20300
K962360IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESScimedx Corp.1996-09-301030
K953495EIA KIT FOR THE DETECTION OF GBM ANTIBODIESScimedx Corp.1996-04-102590
K954105EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIESScimedx Corp.1996-03-192010
K954062EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIESScimedx Corp.1996-03-192030

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