510(k) K103788 ยท CFR Hexokinase, Glucose
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
| Applicant | HORIBA ABX SAS, Montpellier, FR |
| Decision | Substantially Equivalent, Nov 8, 2011 |
| Received | Dec 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2013 | Horiba Instruments, Inc dba Horiba Medical PENTRA C200, Part Number: A11A01629.
The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro d Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.