More Diagnostics: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “More Diagnostics” (first 1993, latest 2008), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 | 2 |
| LAS | Drug Specific Control Materials | 2 | 2 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| GIL | Plasma, Fibrinogen Control | 1 | 1 |
Review panels
- Clinical Chemistry (10)
- Hematology (3)
- Clinical Toxicology (3)
Most recent More Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | LAS | 2008-01-30 | 170 |
| K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 | JJY | 2005-03-18 | 58 |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | JJT | 1998-08-21 | 9 |
| K980331 | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S | DIF | 1998-03-16 | 47 |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | JJT | 1997-08-29 | 18 |
| K970778 | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 | JJX | 1997-04-17 | 44 |
| K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 | GIL | 1995-08-24 | 247 |
| K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS | DAP | 1995-06-15 | 331 |
| K944999 | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 | JJX | 1995-06-06 | 236 |
| K941876 | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 | JJY | 1994-07-28 | 101 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named More 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 More Diagnostics?
FDA lists 16 510(k) clearances under the applicant name “More Diagnostics” (first 1993, latest 2008), across 7 product codes in 3 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 More Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name More Diagnostics is 80 days.
Which FDA product codes appear under More Diagnostics?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 5); JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, 2).
Next steps
- See all 16 More Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JJX, More 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.