Accumed Intl., Inc.: FDA clearances and approvals
Accumed Intl., Inc. has 12 FDA 510(k) clearances (first 1996, latest 1999), across 6 product codes in 2 review panels. Median 510(k) review time: 80 days.
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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 4 | 4 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 3 | 3 |
| JOY | Device, Automated Cell-Locating | 2 | 2 |
| JTT | Susceptibility Test Powders, Antimicrobial | 1 | 1 |
| LQL | Gram Positive Identification Panel | 1 | 1 |
| MDB | System, Blood Culturing | 1 | 1 |
Review panels
- Microbiology (10)
- Hematology (2)
Most recent Accumed Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984489 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | 1999-02-16 | 61 |
| K983306 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN | LTT | 1998-12-18 | 88 |
| K983310 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN | JTT | 1998-12-17 | 87 |
| K983309 | SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN | LTT | 1998-12-14 | 84 |
| K983301 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN | JWY | 1998-11-25 | 65 |
| K982786 | TRACCELL 2000 SLIDE MAPPING SYSTEM | JOY | 1998-10-16 | 67 |
| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | LQL | 1998-01-22 | 196 |
| K964689 | TRACCELL 2000 SLIDE MAPPING SYSTEM | JOY | 1997-08-18 | 269 |
| K972756 | MODIFICATION OF EST CULTURE SYSTEM II - MYCO | MDB | 1997-08-01 | 63 |
| K965190 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE | JWY | 1997-03-19 | 85 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Accumed Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Accumed Intl., Inc. have?
Accumed Intl., Inc. has 12 FDA 510(k) clearances (first 1996, latest 1999), across 6 product codes in 2 review panels.
How long does FDA take to clear Accumed Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Accumed Intl., Inc.'s cleared 510(k)s is 80 days.
What devices does Accumed Intl., Inc. make?
Its most frequent FDA product codes are JWY (Manual Antimicrobial Susceptibility Test Systems, 4); LTT (Panels, Test, Susceptibility, Antimicrobial, 3); JOY (Device, Automated Cell-Locating, 2).
Has Accumed Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Accumed Intl., Inc. Related entities may recall under other names.
Next steps
- See all 12 Accumed Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Accumed Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.