510(k) K934592 ยท JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
| Applicant | Abaxis, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 6, 1994 |
| Received | Sep 24, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2019 | Abaxis Inc Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) Terminated |
JJG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.