510(k) K060205 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Jul 21, 2006 |
| Received | Jan 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060205
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2021 | MEDLINE INDUSTRIES, LP - Northfield ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 Terminated |
CIC | None listed |
| Sep 24, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646
Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination o Terminated |
JGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.