510(k) K013147 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Oct 24, 2001 |
| Received | Sep 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2006 | Abbott Diabetes Care, Inc. FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502;
Part Number: CAT70676-01 Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.