510(k) K992140 ยท JLB Atp And Creatine Kinase (Enzymatic), Creatine
PICCOLO METLYTE 7 REAGENT DISC
| Applicant | Abaxis, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 26, 1999 |
| Received | Jun 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992140
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Abaxis Inc Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-conta Terminated |
JLB | None listed |
| Sep 17, 2008 | Abaxis Inc Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent dis Terminated |
JLB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.