Drew Scientific, Ltd.
Barrow In Furness, GB
Drew Scientific , Ltd. appears in FDA device records in Barrow In Furness, GB. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Drew Scientific, Ltd. between 1992 and 2007. The busiest year on record is 1992, with 2. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071562 | D3 HEMATOLOGY ANALYZER, MODEL D3 | GKZ | Substantially Equivalent | |
| K070704 | TRILOGY ANALYZER | CGA | Substantially Equivalent | |
| K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT | JJX | Substantially Equivalent | |
| K043378 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT | JIT | Substantially Equivalent | |
| K012152 | DS30 HCY BLOOD COLLECTION TUBES | GIM | Substantially Equivalent | |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | LPS | Substantially Equivalent | |
| K933287 | 745 GLYCOMAT | LCP | Substantially Equivalent | |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | JPD | Substantially Equivalent | |
| K920198 | GLYCOMAT HAEMOGLOBIN ANALYSER | LCP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain