510(k) K053308 ยท GKZ Counter, Differential Cell
ABX MICROS CRP 200, OPTION IM
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Dec 29, 2005 |
| Received | Nov 28, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053308
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2014 | Horiba Instruments, Inc dba Horiba Medical Device Name: ABX PENTRA ML
Model/Part #(s): A11A01652
Lot/Serial #(s): N/A
Software Version(s): All versions are subject to this correction.
Product Usage:
The ABX PENTRA ML is a software data manag Terminated |
JQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.