510(k) K983504 ยท CGA Glucose Oxidase, Glucose
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
| Applicant | Medisense, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jul 9, 1999 |
| Received | Oct 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2002 | Abbott Laboratories, Inc. Precision PCx Test Strips
Part Number: 98757-12 Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.