Dade Microscan, Inc.: FDA clearances and approvals
Dade Microscan, Inc. has 40 FDA 510(k) clearances (first 1996, latest 2005), across 5 product codes in 1 review panel. Median 510(k) review time: 64 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 | 26 | 26 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 10 | 10 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 2 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 1 | 1 |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | 1 | 1 |
Review panels
- Microbiology (40)
Most recent Dade Microscan, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | JWY | 2005-02-14 | 48 |
| K023202 | MICROSCAN SYNERGIES PLUS | JWY | 2002-10-23 | 28 |
| K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN | LTT | 2002-06-20 | 66 |
| K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | JWY | 2002-06-17 | 63 |
| K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | JWY | 2002-06-11 | 74 |
| K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | JWY | 2002-06-06 | 52 |
| K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | JWY | 2002-06-06 | 56 |
| K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME | LTT | 2002-06-06 | 62 |
| K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | JWY | 2002-06-06 | 62 |
| K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN | LTT | 2002-06-06 | 64 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dade Microscan, 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 Dade Microscan, Inc. have?
Dade Microscan, Inc. has 40 FDA 510(k) clearances (first 1996, latest 2005), across 5 product codes in 1 review panel.
How long does FDA take to clear Dade Microscan, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dade Microscan, Inc.'s cleared 510(k)s is 64 days.
What devices does Dade Microscan, Inc. make?
Its most frequent FDA product codes are JWY (Manual Antimicrobial Susceptibility Test Systems, 26); LTT (Panels, Test, Susceptibility, Antimicrobial, 10); LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 2).
Has Dade Microscan, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dade Microscan, Inc. Related entities may recall under other names.
Next steps
- See all 40 Dade Microscan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Dade Microscan, 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.