Atlas FDA

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

Mardx Diagnostics, Inc. — Predicate Candidate Screening

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

130 daysmedian FDA review time
468 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964787MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTMardx Diagnostics, Inc.1997-04-081300
K951709MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEMMardx Diagnostics, Inc.1996-06-074210
K950829MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEMMardx Diagnostics, Inc.1996-06-054680
K960182DSDNA IMMUNOGLOBULIN EIA TEST SYSTEMMardx Diagnostics, Inc.1996-03-20640
K894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEMMardx Diagnostics, Inc.1989-08-21590
K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEMMardx Diagnostics, Inc.1989-08-21630
K892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEMMardx Diagnostics, Inc.1989-08-151340
K890053MARDX LYME DISEASE IGG IFA TEST SYSTEMMardx Diagnostics, Inc.1989-04-181020

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