510(k) K163367 ยท PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
GenetiSure Dx Postnatal Assay
| Applicant | Agilent Technologies, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 11, 2017 |
| Received | Nov 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2025 | Agilent Technologies, Inc. GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A). Open, Classified |
PFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.