510(k) K060768 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Apr 21, 2006 |
| Received | Mar 22, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2020 | Abbott Diabetes Care, Inc. FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 Terminated |
JIN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.