510(k) K113614 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 12, 2013 |
| Received | Dec 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Compact Plus Test Strips
For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip
51 count retail strip; 102 count retail strip; 51 count MedBen strip
51 count Mail Order strip; Sa Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.