Anco Medical Reagents & Assoc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Anco Medical Reagents & Assoc.” (first 1981, latest 1984), across 24 product codes in 2 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| GHM | Test, Sickle Cell | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFD | Sulfophosphovanillin, Colorimetry, Total Lipids | 1 | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 | 1 |
Plus 14 more product codes.
Review panels
- Clinical Chemistry (22)
- Hematology (4)
Most recent Anco Medical Reagents & Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH | JPK | 1984-07-27 | 36 |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | GHM | 1983-07-28 | 45 |
| K821658 | HEMOGLOBIN REAGENT | KHG | 1982-06-25 | 21 |
| K821526 | ACID PHOSPHATASE REAGENT SET | CKE | 1982-06-10 | 20 |
| K821102 | MEGNESIUM REAGENT KIT | JGJ | 1982-05-05 | 15 |
| K820951 | ENZYMATIC CHOLESTEROL KIT | CHH | 1982-04-26 | 20 |
| K820500 | TOTAL LIPID REAGENT SET | CFD | 1982-03-11 | 16 |
| K820491 | SGPT REAGENT SET | CKD | 1982-03-11 | 16 |
| K820466 | SGOT REAGENT SET | CIQ | 1982-03-11 | 17 |
| K812837 | ALKALINE PHOSPHATASE REAGENT SET | CJL | 1982-01-29 | 112 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anco Medical Reagents & Assoc..
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.
- Anco Merchandise Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Anco Medical Reagents & Assoc.?
FDA lists 26 510(k) clearances under the applicant name “Anco Medical Reagents & Assoc.” (first 1981, latest 1984), across 24 product codes in 2 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 Anco Medical Reagents & Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anco Medical Reagents & Assoc. is 20 days.
Which FDA product codes appear under Anco Medical Reagents & Assoc.?
The most frequent FDA product codes under this applicant name are GHM (Test, Sickle Cell, 2); JIS (Calibrator, Primary, 2); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Next steps
- See all 26 Anco Medical Reagents & Assoc. clearances with predicates and recalls
- Run predicate analysis for product code GHM, Anco Medical Reagents & Assoc.'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.