Mrl Diagnostics: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mrl Diagnostics” (first 1994, latest 2000), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 203 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 | 2 | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 | 1 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 1 | 1 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 1 | 1 |
Review panels
- Microbiology (7)
Most recent Mrl Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000238 | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G | LGC | 2000-04-14 | 78 |
| K993754 | HSV-1 ELISA IGG, MODEL EL0910G | MXJ | 2000-02-09 | 96 |
| K993724 | HSV-2 ELISA IGG, MODEL EL0920G | MYF | 2000-02-01 | 90 |
| K971007 | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) | LSR | 1998-06-01 | 439 |
| K971006 | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) | LSR | 1998-06-01 | 439 |
| K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY | LLM | 1995-07-21 | 203 |
| K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY | LJN | 1994-04-26 | 396 |
Recalls
openFDA lists no recalls under a recalling firm named Mrl Diagnostics.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mrl Diagnostics?
FDA lists 7 510(k) clearances under the applicant name “Mrl Diagnostics” (first 1994, latest 2000), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mrl Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mrl Diagnostics is 203 days.
Which FDA product codes appear under Mrl Diagnostics?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 2); LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific, 1); LJN (Antibody Igm, If, Epstein-Barr Virus, 1).
Next steps
- See all 7 Mrl Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code LSR, Mrl Diagnostics'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.