Diamond Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Diamond Diagnostics, Inc.” (first 2001, latest 2020), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 123 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 | 4 | 138 |
| 2013 | 1 | 111 |
| 2014 | 1 | 242 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 212 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Diamond Diagnostics, Inc. took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIT | Calibrator, Secondary | 9 | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 | 6 |
| JGS | Electrode, Ion Specific, Sodium | 4 | 4 |
| CEM | Electrode, Ion Specific, Potassium | 2 | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (26)
Most recent Diamond Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | CEM | 2020-10-01 | 212 |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | JIT | 2014-08-08 | 242 |
| K124009 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C | JJY | 2013-04-17 | 111 |
| K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH | JIT | 2012-12-20 | 260 |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | CEM | 2012-08-30 | 147 |
| K121140 | PROLYTE ELECTROLYTE ANALYZER | JGS | 2012-08-22 | 128 |
| K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 | JIT | 2012-04-17 | 49 |
| K103364 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL | JJY | 2011-05-06 | 171 |
| K102959 | PROLYTE ELECTROLYTE ANALYZER | JGS | 2011-01-14 | 101 |
| K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D | JIT | 2010-06-24 | 239 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diamond 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.
- Diamond Medical, Inc. (6 510(k)s)
- Diamond Medical Equipment, Inc. (3 510(k)s)
- Diamond Sensor Systems (3 510(k)s)
- Diamond Shamrock Corp. (2 510(k)s)
- Diamond Age Systems, Inc. (1 510(k)s)
- Diamond Brothers Trading Co., Inc. (1 510(k)s)
- Diamond Electro-Tech, Inc. (1 510(k)s)
- Diamond Mark International Co., Ltd. (1 510(k)s)
- Diamond Orthopedic, LLC (1 510(k)s)
- Diamond Orthotic Laboratory (1 510(k)s)
- Diamond Rotary and Carbide Intl. (1 510(k)s)
- Diamond Systems USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diamond Diagnostics, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Diamond Diagnostics, Inc.” (first 2001, latest 2020), across 9 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 Diamond Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diamond Diagnostics, Inc. is 123 days.
Which FDA product codes appear under Diamond Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 9); JJY (Multi-Analyte Controls, All Kinds (Assayed), 6); JGS (Electrode, Ion Specific, Sodium, 4).
Next steps
- See all 26 Diamond Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Diamond 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.