510(k) K081276 ยท CFR Hexokinase, Glucose
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Sep 12, 2008 |
| Received | May 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric ac Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.