510(k) K952875 ยท CGA Glucose Oxidase, Glucose
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 21, 1995 |
| Received | Jun 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2005 | Roche Diagnostics Corp. ACCU-CHEK Instant Meter; Catalog numbers 914 and 924. Terminated |
CGA | None listed |
| Jul 13, 2005 | Roche Diagnostics Corp. ACCU-CHEK Instant Care Kit; Catalog number 91490. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.