Accra Laboratories, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Accra Laboratories, Inc.” (first 1981, latest 1985), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 23 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 |
|---|---|---|---|
| IAF | Wright'S Stain | 6 | 6 |
| JTS | Stains, Microbiologic | 4 | 4 |
| HYK | Hematoxylin Harris'S | 2 | 2 |
| HYB | Eosin Y | 1 | 1 |
| HYJ | Hematoxylin | 1 | 1 |
| HZJ | Stain, Papanicolau | 1 | 1 |
| HZL | Phloxine B | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
| KSL | Solution, Copper Sulfate For Specific Gravity Determinations | 1 | 1 |
Plus 1 more product codes.
Review panels
- Pathology (13)
- Microbiology (4)
- Hematology (1)
- Radiology (1)
- Clinical Toxicology (1)
Most recent Accra Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851494 | TWO-STEP ACID FAST BACTERIA STAIN | JTS | 1985-04-29 | 14 |
| K851493 | KINYOUN ACID FAST STAIN KIT | JTS | 1985-04-29 | 14 |
| K843427 | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | HZJ | 1984-10-02 | 28 |
| K843425 | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | HYK | 1984-10-02 | 28 |
| K843428 | BIOFIX | LDZ | 1984-09-27 | 23 |
| K843426 | EOSIN Y 1% ALCOHOLIC | HYB | 1984-09-27 | 23 |
| K843429 | GRAM STAIN SET W/STABILIZED IODINE | JTS | 1984-09-14 | 10 |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | HYJ | 1983-06-08 | 65 |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | IAF | 1983-03-17 | 23 |
| K823329 | PAPINCOLABU STAIN EA-36/50/65 & OG-6 | HZL | 1982-12-28 | 50 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Accra Laboratories, 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 Accra Laboratories, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Accra Laboratories, Inc.” (first 1981, latest 1985), across 11 product codes in 5 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 Accra Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Accra Laboratories, Inc. is 23 days.
Which FDA product codes appear under Accra Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are IAF (Wright'S Stain, 6); JTS (Stains, Microbiologic, 4); HYK (Hematoxylin Harris'S, 2).
Next steps
- See all 20 Accra Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IAF, Accra Laboratories, 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 (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.