Anatech, Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Anatech, Ltd.” (first 1984, latest 1988), across 10 product codes in 1 review panel. 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 |
|---|---|---|---|
| IFP | Formalin, Neutral Buffered | 3 | 3 |
| HYJ | Hematoxylin | 2 | 2 |
| KEM | Agent, Clearing | 2 | 2 |
| HYK | Hematoxylin Harris'S | 1 | 1 |
| IGE | Solution, Formalin Ammonium Bromide | 1 | 1 |
| IGG | Formaldehyde (Formalin, Formol) | 1 | 1 |
| KQC | Stains, Hematology | 1 | 1 |
| LDX | Fixative, Metallic Containing | 1 | 1 |
| LEB | Mounting Media | 1 | 1 |
| PPM | General Purpose Reagent | 1 | 1 |
Review panels
- Pathology (14)
Most recent Anatech, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882874 | ZINC FORMALIN | LDX | 1988-07-28 | 17 |
| K882873 | FIELDTEX HEMATOXYLIN | KQC | 1988-07-28 | 17 |
| K882268 | ZINC FORMALIN CONCENTRATE | IGG | 1988-06-15 | 15 |
| K881282 | XYLENE | KEM | 1988-04-05 | 11 |
| K872663 | DRY-FORM | IFP | 1987-08-06 | 29 |
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | HYJ | 1987-07-09 | 15 |
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | HYJ | 1987-07-09 | 15 |
| K872498 | HARRIS HEMATOXYLIN | HYK | 1987-07-09 | 15 |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | IFP | 1987-03-31 | 28 |
| K842940 | CBA FORMALIN | IFP | 1984-08-28 | 34 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anatech, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Anatech, Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Anatech, Ltd.” (first 1984, latest 1988), across 10 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 Anatech, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anatech, Ltd. is 20 days.
Which FDA product codes appear under Anatech, Ltd.?
The most frequent FDA product codes under this applicant name are IFP (Formalin, Neutral Buffered, 3); HYJ (Hematoxylin, 2); KEM (Agent, Clearing, 2).
Next steps
- See all 14 Anatech, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IFP, Anatech, 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.