510(k) K100101 ยท KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
GSP NEONATALGALT KIT, MODEL 3303-001U
| Applicant | Perkinelmer, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 11, 2010 |
| Received | Jan 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | WALLAC OY GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic.
Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE. Open, Classified |
KQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.