510(k) K924475 ยท CGA Glucose Oxidase, Glucose
ACCUDATA GLUCOSE TEST STATION
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 13, 1992 |
| Received | Sep 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2006 | Roche Diagnostics Corp. AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777. Terminated |
CGA | None listed |
| Jun 11, 2005 | Roche Diagnostics Corp. Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001. Terminated |
CGA | None listed |
| Jun 11, 2005 | Roche Diagnostics Corp. Roche brand AccuData GTS System; Catalog number 404, material number 03136833001. Terminated |
CGA | None listed |
| Jun 11, 2005 | Roche Diagnostics Corp. Roche brand AccuData GTS/GTS Plus System
Replacement Base/Module; Catalog number 3426050, material number 03426050001. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.