510(k) K983047 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK HQ SYSTEM
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 5, 1999 |
| Received | Sep 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents include two Accu-Chek Advantage monitors including Cat. no. 2138018 and Cat. no. 2138026. Ref. nos. Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.