Company ยท GB
Drew Scientific , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2007. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CGA | Glucose Oxidase, Glucose | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 |
| GKZ | Counter, Differential Cell | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JPD | Hemoglobin A2 Quantitation | 1 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2007 | K071562 | D3 HEMATOLOGY ANALYZER, MODEL D3 Drew Scientific, Inc. | GKZ |
| Jul 13, 2007 | K070704 | TRILOGY ANALYZER Drew Scientific, Inc. | CGA |
| Jun 19, 2006 | K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT Drew Scientific , Ltd., GB | JJX |
| Dec 29, 2004 | K043378 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT Drew Scientific , Ltd., GB | JIT |
| Sep 18, 2001 | K012152 | DS30 HCY BLOOD COLLECTION TUBES Drew Scientific , Ltd., GB | GIM |
| Feb 11, 1999 | K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT Drew Scientific , Ltd., GB | LPS |
| Sep 9, 1993 | K933287 | 745 GLYCOMAT Drew Scientific , Ltd., GB | LCP |
| Nov 16, 1992 | K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT Drew Scientific , Ltd., GB | JPD |
| Jul 21, 1992 | K920198 | GLYCOMAT HAEMOGLOBIN ANALYSER Drew Scientific , Ltd., GB | LCP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||