510(k) K070249 ยท CIC Cresolphthalein Complexone, Calcium
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Apr 26, 2007 |
| Received | Jan 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Calcium CP Reagent, Model # A11A01633
Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone minera Terminated |
CIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.