Amresco, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Amresco, Inc.” (first 1981, latest 1991), across 26 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 3 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 | 3 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 2 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 | 2 |
Plus 16 more product codes.
Review panels
- Clinical Chemistry (38)
Most recent Amresco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905618 | GGT REAGENT | JPZ | 1991-02-26 | 74 |
| K904468 | DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 | CIG | 1991-01-17 | 108 |
| K905684 | ALKALINE PHOSPHATASE | CJE | 1990-12-28 | 9 |
| K905544 | MAGNESIUM REAGENT | JGJ | 1990-12-27 | 16 |
| K905284 | HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 | LBR | 1990-12-11 | 18 |
| K904004 | AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 | CGS | 1990-12-11 | 104 |
| K905096 | GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 | JQB | 1990-11-28 | 15 |
| K904381 | DIAZO COLORIMENTRY DIRECT BILIRUBIN | CIG | 1990-10-12 | 16 |
| K903775 | CREATINE PHOSPHOKINASE | CGS | 1990-10-04 | 45 |
| K903829 | AST REAGENT | CIT | 1990-09-25 | 35 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amresco, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Amresco, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Amresco, Inc.” (first 1981, latest 1991), across 26 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 Amresco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amresco, Inc. is 34 days.
Which FDA product codes appear under Amresco, Inc.?
The most frequent FDA product codes under this applicant name are CGX (Alkaline Picrate, Colorimetry, Creatinine, 3); CIG (Diazo Colorimetry, Bilirubin, 3); CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 3).
Next steps
- See all 39 Amresco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGX, Amresco, 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.