510(k) K970862 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
SPINALSCOPICS
| Applicant | Quantimetrix Corp., Redondo Beach CA, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Mar 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix SpinalScopics Spinal Fluid Cell Count Control.
Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient c Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.