510(k) K982002 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK COMFORT CURVE TEST STRIP
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 2, 1998 |
| Received | Jun 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2003 | Roche Diagnostics Corp. Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141. Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.