Drew Scientific , Ltd.: FDA clearances and approvals
Drew Scientific , Ltd. has 9 FDA 510(k) clearances (first 1992, latest 2007), across 8 product codes in 2 review panels. Median 510(k) review time: 112 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 | 1 |
| GKZ | Counter, Differential Cell | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JPD | Hemoglobin A2 Quantitation | 1 | 1 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Hematology (4)
Most recent Drew Scientific , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071562 | D3 HEMATOLOGY ANALYZER, MODEL D3 | GKZ | 2007-12-11 | 187 |
| K070704 | TRILOGY ANALYZER | CGA | 2007-07-13 | 122 |
| K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT | JJX | 2006-06-19 | 112 |
| K043378 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT | JIT | 2004-12-29 | 21 |
| K012152 | DS30 HCY BLOOD COLLECTION TUBES | GIM | 2001-09-18 | 69 |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | LPS | 1999-02-11 | 248 |
| K933287 | 745 GLYCOMAT | LCP | 1993-09-09 | 65 |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | JPD | 1992-11-16 | 73 |
| K920198 | GLYCOMAT HAEMOGLOBIN ANALYSER | LCP | 1992-07-21 | 188 |
Recalls
openFDA lists no recalls under a recalling firm named Drew Scientific , Ltd..
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 Drew Scientific , Ltd. have?
Drew Scientific , Ltd. has 9 FDA 510(k) clearances (first 1992, latest 2007), across 8 product codes in 2 review panels.
How long does FDA take to clear Drew Scientific , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Drew Scientific , Ltd.'s cleared 510(k)s is 112 days.
What devices does Drew Scientific , Ltd. make?
Its most frequent FDA product codes are LCP (Assay, Glycosylated Hemoglobin, 2); CGA (Glucose Oxidase, Glucose, 1); GIM (Tubes, Vacuum Sample, With Anticoagulant, 1).
Has Drew Scientific , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Drew Scientific , Ltd. Related entities may recall under other names.
Next steps
- See all 9 Drew Scientific , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Drew Scientific , Ltd.'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.