510(k) K072869 ยท GKZ Counter, Differential Cell
POINTCARE NOW SYSTEM
| Applicant | Pointcare Technologies, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jan 14, 2008 |
| Received | Oct 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072869
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2012 | Pointcare Technologies, Inc. PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack,
Part Number :30034
In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positi Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.