510(k) K093384 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
| Applicant | Diamond Diagnostics, Inc., Holliston MA, US |
| Decision | Substantially Equivalent, Mar 10, 2010 |
| Received | Oct 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093384
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2019 | Randox Laboratories Ltd. Randox Blood Gas Control Level 2 -Model BG5002.
In-vitro Diagnostic Quality control of Blood Gas analysis
This product is intended for in vitro diagnostic use, in the quality control of Blood Gas ana Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.