510(k) K973662 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 15, 1997 |
| Received | Sep 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and Ref. no. 03144852001 with meter model no Terminated |
LFR | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Complete blood glucose monitor, Ref. no. 516; Catalog nos. 03266770001 and 03871983001 with meter model no. 200 and Catalog no. 03871983001 with meter model number 250. Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.