Diagnostic Solutions, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Diagnostic Solutions, Inc.” (first 1980, latest 1994), across 21 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 4 | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 11 more product codes.
Review panels
- Clinical Chemistry (24)
Most recent Diagnostic Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | CGA | 1994-01-11 | 113 |
| K924398 | UNI-CHECK REAGENT STRIP | CGA | 1992-12-23 | 114 |
| K921825 | QUICK-CHECK II REAGENT STRIP | CGA | 1992-08-18 | 124 |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | CKA | 1980-05-30 | 65 |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | KMS | 1980-05-30 | 65 |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | CEM | 1980-05-28 | 63 |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | CFJ | 1980-05-28 | 63 |
| K800690 | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS | CEO | 1980-05-28 | 63 |
| K800688 | REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC | CIT | 1980-05-28 | 63 |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | CGA | 1980-05-28 | 63 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Solutions, 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.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Systems Laboratories, Inc. (94 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Specialties (8 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Solutions, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Diagnostic Solutions, Inc.” (first 1980, latest 1994), across 21 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 Diagnostic Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Solutions, Inc. is 63 days.
Which FDA product codes appear under Diagnostic Solutions, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 4); CIG (Diazo Colorimetry, Bilirubin, 2); CDH (Acid, Uric, Phosphotungstate Reduction, 1).
Next steps
- See all 26 Diagnostic Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Diagnostic Solutions, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.