Mardx Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mardx Diagnostics, Inc.” (first 1989, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 6 | 6 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
Review panels
- Microbiology (6)
- Immunology (2)
Most recent Mardx Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964787 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM | LLL | 1997-04-08 | 130 |
| K951709 | MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM | LSR | 1996-06-07 | 421 |
| K950829 | MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM | LSR | 1996-06-05 | 468 |
| K960182 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | LRM | 1996-03-20 | 64 |
| K894293 | MARDX LYME DISEASE EIA (IGM) TEST SYSTEM | LSR | 1989-08-21 | 59 |
| K894224 | MARDX LYME DISEASE EIA (IGG) TEST SYSTEM | LSR | 1989-08-21 | 63 |
| K892206 | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM | LSR | 1989-08-15 | 134 |
| K890053 | MARDX LYME DISEASE IGG IFA TEST SYSTEM | LSR | 1989-04-18 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Mardx Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mardx, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mardx Diagnostics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Mardx Diagnostics, Inc.” (first 1989, latest 1997), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mardx Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mardx Diagnostics, Inc. is 116 days.
Which FDA product codes appear under Mardx Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 6); LLL (Extractable Antinuclear Antibody, Antigen And Control, 1); LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control, 1).
Next steps
- See all 8 Mardx Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSR, Mardx Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.