Diagnostic Chemicals, Ltd. (Usa): FDA filings under this applicant name
FDA lists 77 510(k) clearances under the applicant name “Diagnostic Chemicals, Ltd. (Usa)” (first 1984, latest 2002), across 47 product codes in 4 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 5 | 5 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 3 | 3 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 | 3 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| KHS | Enzymatic, Carbon-Dioxide | 3 | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 | 2 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 2 | 2 |
| CFR | Hexokinase, Glucose | 2 | 2 |
Plus 37 more product codes.
Review panels
- Clinical Chemistry (68)
- Clinical Toxicology (5)
- Microbiology (2)
- Immunology (1)
Most recent Diagnostic Chemicals, Ltd. (Usa) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | JIR | 2002-08-23 | 22 |
| K974874 | BILIRUBIN-SL (TOTAL) ASSAY | CIG | 1998-02-12 | 45 |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | JIF | 1994-08-02 | 433 |
| K932766 | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) | LBR | 1993-12-10 | 185 |
| K932555 | DC-LINEATE CAT. NO. SE-091 | JIS | 1993-08-19 | 85 |
| K925877 | DC-UIBC-CAL | JIS | 1993-03-18 | 119 |
| K912825 | MAGNESIUM ASSAY KIT, CAT.# 100-12 | JGJ | 1991-07-26 | 30 |
| K895964 | DCL SYPHILIS-M CATALOG NO. 600-80 | LIP | 1991-01-08 | 454 |
| K895965 | DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 | LIP | 1990-12-26 | 441 |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | JFM | 1990-11-20 | 36 |
67 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Chemicals, Ltd. (Usa).
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. (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 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. (Usa)?
FDA lists 77 510(k) clearances under the applicant name “Diagnostic Chemicals, Ltd. (Usa)” (first 1984, latest 2002), across 47 product codes in 4 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. (Usa)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Chemicals, Ltd. (Usa) is 43 days.
Which FDA product codes appear under Diagnostic Chemicals, Ltd. (Usa)?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 5); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 3); CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 3).
Next steps
- See all 77 Diagnostic Chemicals, Ltd. (Usa) clearances with predicates and recalls
- Run predicate analysis for product code CIG, Diagnostic Chemicals, Ltd. (Usa)'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.