510(k) K930979 ยท CGA Glucose Oxidase, Glucose
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 8, 1993 |
| Received | Feb 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 with meter model number 870; Ref. no. 03002531001 with meter model number 33304510; Ref. no. 03002531001 with me Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500; Ref. no. 0385633001 with meter model no. 768. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 2138930. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number 2138930. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage (Managed Care Kit) 100- value memory with time and date, Not for Retail Sale,
Cat. No. 3000389; Ref no. 03000389001 with meter model no. 2138930. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338; Ref no. 03000338001 with meter model no. 2138930. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog no. 03000320001 with meter model no. 2138930. Terminated |
CGA | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with meter model no. 3288650. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.