Diagnostic Chemicals , Ltd.: FDA clearances and approvals
Diagnostic Chemicals , Ltd. has 66 FDA 510(k) clearances (first 1994, latest 2007), across 36 product codes in 3 review panels. Median 510(k) review time: 65 days. openFDA lists 6 product recalls by a recalling firm named Diagnostic Chemicals , Ltd.
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 |
|---|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 4 | 4 |
| KHS | Enzymatic, Carbon-Dioxide | 4 | 4 |
| LDP | Colorimetry, Acetaminophen | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 3 |
| DKJ | Colorimetry, Salicylate | 3 | 3 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CFR | Hexokinase, Glucose | 2 | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 2 |
Plus 26 more product codes.
Review panels
- Clinical Chemistry (51)
- Clinical Toxicology (13)
- Immunology (2)
Most recent Diagnostic Chemicals , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | JFY | 2007-06-22 | 133 |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | JGJ | 2007-01-19 | 88 |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | DCK | 2006-04-28 | 99 |
| K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 | JIT | 2006-04-24 | 95 |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | CJY | 2005-11-10 | 134 |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | DCF | 2005-07-05 | 56 |
| K042330 | ACETAMINOPHEN-SL ASSAY | LDP | 2005-01-07 | 133 |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 | KHS | 2004-12-27 | 118 |
| K042329 | SALICYLATE-SL ASSAY | DKJ | 2004-12-27 | 122 |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | LBS | 2004-11-23 | 127 |
56 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2010-11-10.
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 Diagnostic Chemicals , Ltd. have?
Diagnostic Chemicals , Ltd. has 66 FDA 510(k) clearances (first 1994, latest 2007), across 36 product codes in 3 review panels.
How long does FDA take to clear Diagnostic Chemicals , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Diagnostic Chemicals , Ltd.'s cleared 510(k)s is 65 days.
What devices does Diagnostic Chemicals , Ltd. make?
Its most frequent FDA product codes are DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, 4); KHS (Enzymatic, Carbon-Dioxide, 4); LDP (Colorimetry, Acetaminophen, 4).
Has Diagnostic Chemicals , Ltd. had device recalls?
openFDA lists 6 product recalls in 5 recall events by a recalling firm whose name matches Diagnostic Chemicals , Ltd; the most recent began 2010-11-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 66 Diagnostic Chemicals , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DIC, Diagnostic Chemicals , Ltd.'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.