Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Accra Laboratories, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
88 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851493 | KINYOUN ACID FAST STAIN KIT | Accra Laboratories, Inc. | 1985-04-29 | 14 | 0 |
| K851494 | TWO-STEP ACID FAST BACTERIA STAIN | Accra Laboratories, Inc. | 1985-04-29 | 14 | 0 |
| K843427 | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | Accra Laboratories, Inc. | 1984-10-02 | 28 | 0 |
| K843425 | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | Accra Laboratories, Inc. | 1984-10-02 | 28 | 0 |
| K843426 | EOSIN Y 1% ALCOHOLIC | Accra Laboratories, Inc. | 1984-09-27 | 23 | 0 |
| K843428 | BIOFIX | Accra Laboratories, Inc. | 1984-09-27 | 23 | 0 |
| K843429 | GRAM STAIN SET W/STABILIZED IODINE | Accra Laboratories, Inc. | 1984-09-14 | 10 | 0 |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Accra Laboratories, Inc. | 1983-06-08 | 65 | 0 |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | Accra Laboratories, Inc. | 1983-03-17 | 23 | 0 |
| K823328 | HARRIS HEMATOXYLIN | Accra Laboratories, Inc. | 1982-12-28 | 50 | 0 |
| K823329 | PAPINCOLABU STAIN EA-36/50/65 & OG-6 | Accra Laboratories, Inc. | 1982-12-28 | 50 | 0 |
| K822602 | HEMACOUNT WRIGHT GIEMSA STAIN PACK | Accra Laboratories, Inc. | 1982-09-17 | 21 | 0 |
| K821457 | HEMACOUNT WRIGHTS STAIN PACK II #55952 | Accra Laboratories, Inc. | 1982-06-01 | 15 | 0 |
| K812848 | ACCRA LAB HEMOTOLOGY | Accra Laboratories, Inc. | 1981-10-23 | 14 | 0 |
| K812504 | ACCRA LAB WRIGHT STAIN | Accra Laboratories, Inc. | 1981-09-23 | 22 | 0 |
| K811780 | ACCRA-LAB GRAM STAIN SET 55760 | Accra Laboratories, Inc. | 1981-07-27 | 34 | 0 |
| K811400 | HEMAQUIK | Accra Laboratories, Inc. | 1981-06-18 | 31 | 0 |
| K810495 | STAT STAIN SET | Accra Laboratories, Inc. | 1981-03-17 | 21 | 0 |
| K803095 | COPPER SULFATE SOLUTION SP. GR.1.055 | Accra Laboratories, Inc. | 1981-03-06 | 88 | 0 |
| K803094 | COPPER SULFATE SOLUTION SP. GR.1.053 | Accra Laboratories, Inc. | 1981-03-06 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda