Trace Scientific , Ltd.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Trace Scientific , Ltd.” (first 1986, latest 1998), across 32 product codes in 3 review panels. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 4 | 4 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 | 4 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 | 3 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 3 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 3 | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 2 |
Plus 22 more product codes.
Review panels
- Clinical Chemistry (51)
- Hematology (2)
- Immunology (1)
Most recent Trace Scientific , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | DBM | 1998-09-17 | 93 |
| K981123 | UREA | CDQ | 1998-04-24 | 28 |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | CHH | 1996-09-27 | 65 |
| K961114 | AST INCORPORATING DST | CIT | 1996-05-23 | 64 |
| K961123 | ALT INCORPORATING DST | CKA | 1996-04-25 | 35 |
| K952488 | TRACE COBAS MIRA RANGE | CIX | 1995-10-13 | 136 |
| K932713 | TRACE TRANSFERRIN REAGENT | DDQ | 1993-09-30 | 118 |
| K923322 | TRACE ALBUMIN-MR REAGENT | CIX | 1992-09-11 | 66 |
| K914731 | TRACE GAMMA GT-SS REAGENT | JQB | 1991-11-19 | 29 |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | CIG | 1991-07-17 | 82 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Trace Scientific , Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Trace Scientific , Ltd. (a text match, not an official crosswalk):
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.
- Trace America, Inc. (22 510(k)s)
- Trace Medical Equipment, Inc. (2 510(k)s)
- Trace Analytical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trace Scientific , Ltd.?
FDA lists 55 510(k) clearances under the applicant name “Trace Scientific , Ltd.” (first 1986, latest 1998), across 32 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 Trace Scientific , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trace Scientific , Ltd. is 57 days.
Which FDA product codes appear under Trace Scientific , Ltd.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 4); CIG (Diazo Colorimetry, Bilirubin, 4); CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 4).
Next steps
- See all 55 Trace Scientific , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Trace Scientific , 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.