510(k) K010598 ยท JPK Mixture, Hematology Quality Control
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
| Applicant | Quantimetrix Corp., Redondo Beach CA, US |
| Decision | Substantially Equivalent, Mar 23, 2001 |
| Received | Feb 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix Synovialscopics Synovial Fluid Control.
Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial flui Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.