Panels › Immunology › Product code PFX · Class 2
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
Regulation 866.5920
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in PFX
| Company | 510(k)s | Recalls |
|---|---|---|
| Affymetrix, Inc. | 1 | 1 |
| Agilent Technologies, Inc. | 1 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2017 | K163367 | GenetiSure Dx Postnatal Assay Agilent Technologies, Inc. | PFX |
| Jan 17, 2014 | DEN130018 | CYTOSCAN(R) DX Affymetrix, Inc. | PFX |
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