510(k) K950481 ยท JIA Enzymatic Methods, Galactose
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
| Applicant | Isolab, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Feb 1, 1996 |
| Received | Feb 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Perkin Elmer Life and Analytical Sciences Inc Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000 Terminated |
JIA | None listed |
| Jul 20, 2004 | Perkin Elmer Life and Analytical Sciences Inc Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000 Terminated |
JIA | None listed |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays. Terminated |
JIA | None listed |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays. Terminated |
JIA | None listed |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays. Terminated |
JIA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.