Diagnostic Chemicals , Ltd.: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Diagnostic Chemicals , Ltd.” (first 1994, latest 2007), across 36 product codes in 3 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| 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 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 Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(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 Chemicals , Ltd.?
FDA lists 66 510(k) clearances under the applicant name “Diagnostic Chemicals , Ltd.” (first 1994, latest 2007), across 36 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 Diagnostic Chemicals , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Chemicals , Ltd. is 65 days.
Which FDA product codes appear under Diagnostic Chemicals , Ltd.?
The most frequent FDA product codes under this applicant name are DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, 4); KHS (Enzymatic, Carbon-Dioxide, 4); LDP (Colorimetry, Acetaminophen, 4).
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. 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.