CYTOSCAN(R) DX
FDA 510(k) clearance DEN130018 · decided 2014-01-17
Clearance details
- K-number
- DEN130018
- Device name
- CYTOSCAN(R) DX
- Applicant
- Affymetrix, Inc.
- Decision
- Unknown
- Date received
- 2013-12-18
- Decision date
- 2014-01-17
- Days to decision
- 30 days
- Clearance type
- Post-NSE
- Product code
- PFX
- Device class
- 2
- Regulation number
- 866.5920
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GenetiSure Dx Postnatal Assay (K163367) | Agilent Technologies, Inc. | 2017-08-11 |
Recalls involving this device
No recalls on record reference this clearance.