U. S. Diagnostics, Inc.: FDA clearances and approvals
U. S. Diagnostics, Inc. has 22 FDA 510(k) clearances (first 1986, latest 2011), across 14 product codes in 3 review panels. Median 510(k) review time: 48 days.
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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 4 | 4 |
| NBW | System, Test, Blood Glucose, Over The Counter | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| GFD | Dermatome | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent U. S. Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2011-09-21 | 218 |
| K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | NBW | 2009-02-20 | 199 |
| K061431 | EASYGLUCO, MODEL IGM-0002 G2 | CGA | 2007-01-12 | 233 |
| K051651 | G4, MODEL IGM-0004 | NBW | 2006-04-14 | 297 |
| K870687 | COAGULATION CONTROL, LEVEL III | JPA | 1987-04-20 | 60 |
| K870686 | COAGULATION CONTROL, LEVEL II | JPA | 1987-04-20 | 60 |
| K870685 | COAGULATION CONTROL, LEVEL I | JPA | 1987-04-20 | 60 |
| K870596 | PROTHROMBIN TIME TEST | GJS | 1987-04-20 | 69 |
| K871283 | CYANMETHEMOGLOBIN STANDARD | KRZ | 1987-04-15 | 15 |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | JJT | 1987-04-13 | 47 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named U. S. Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does U. S. Diagnostics, Inc. have?
U. S. Diagnostics, Inc. has 22 FDA 510(k) clearances (first 1986, latest 2011), across 14 product codes in 3 review panels.
How long does FDA take to clear U. S. Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across U. S. Diagnostics, Inc.'s cleared 510(k)s is 48 days.
What devices does U. S. Diagnostics, Inc. make?
Its most frequent FDA product codes are JPA (System, Multipurpose For In Vitro Coagulation Studies, 4); NBW (System, Test, Blood Glucose, Over The Counter, 3); CGA (Glucose Oxidase, Glucose, 2).
Has U. S. Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching U. S. Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 22 U. S. Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPA, U. S. Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.