Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Drew Scientific , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
248 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT | Drew Scientific , Ltd. | 2006-06-19 | 112 | 0 |
| K043378 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRAT | Drew Scientific , Ltd. | 2004-12-29 | 21 | 0 |
| K012152 | DS30 HCY BLOOD COLLECTION TUBES | Drew Scientific , Ltd. | 2001-09-18 | 69 | 0 |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | Drew Scientific , Ltd. | 1999-02-11 | 248 | 0 |
| K933287 | 745 GLYCOMAT | Drew Scientific , Ltd. | 1993-09-09 | 65 | 0 |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | Drew Scientific , Ltd. | 1992-11-16 | 73 | 0 |
| K920198 | GLYCOMAT HAEMOGLOBIN ANALYSER | Drew Scientific , Ltd. | 1992-07-21 | 188 | 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