510(k) K950803 ยท JJT Enzyme Controls (Assayed And Unassayed)
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
| Applicant | Isolab, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Sep 21, 1995 |
| Received | Feb 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2003 | PerkinElmer Life Sciences Inc Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100. Terminated |
JLJ | None listed |
| May 29, 2003 | PerkinElmer LIfe Sciences Inc Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100. Terminated |
JJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.