510(k) K031890 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
| Applicant | Medical Analysis Systems, Inc., Camarillo CA, US |
| Decision | Substantially Equivalent, Jul 16, 2003 |
| Received | Jun 18, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2013 | Microgenics Corporation Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA
MAS Bilirubin is intended for use as a cons Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.