510(k) K022171 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK COMPACT SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 23, 2002 |
| Received | Jul 3, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022171
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2005 | Roche Diagnostics Corp. ACCU-CHEK Compact Meter; catalog number 3183572. Terminated |
NBW | None listed |
| Jul 12, 2005 | Roche Diagnostics Corp. ACCU-CHEK Compact Care Kit; catalog number 3149137. Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.