510(k) DEN130018
- Device
- CYTOSCAN(R) DX
- Applicant
- Affymetrix, Inc.
- 510(k) number
- DEN130018
- Product code
- PFX
- Decision
- Unknown (DENG)
- Decision date
- 2014-01-17
- Date received
- 2013-12-18
- Regulation
- 866.5920
- Classification name
- System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- ERIC FUNG
- Address
- 3420 Central Expy. . Santa Clara CA US 95051 95051
FDA Registration Numbers#
- 3003314809
- 3009189893
- 3010286073
- 2916205
- 3009731198
- 3009573214
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PFX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163367 | GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | 2017-08-11 |