GenetiSure Dx Postnatal Assay
FDA 510(k) clearance K163367 · decided 2017-08-11
Clearance details
- K-number
- K163367
- Device name
- GenetiSure Dx Postnatal Assay
- Applicant
- Agilent Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-30
- Decision date
- 2017-08-11
- Days to decision
- 254 days
- Clearance type
- Traditional
- 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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| CYTOSCAN(R) DX (DEN130018) | Affymetrix, Inc. | 2014-01-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, recall (Z-1544-2025) | Agilent Technologies, Inc. | 2025-04-08 |
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|---|---|---|
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| MAGE-A4 IHC 1F9 pharmDx (P230016/S002) | Agilent Technologies, Inc. | 2025-06-27 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S030) | Agilent Technologies, Inc. | 2025-06-27 |
| Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S002) | Agilent Technologies, Inc. | 2025-02-28 |
| PD-L1 IHC 22C3 pharmDx (P150013/S029) | Agilent Technologies, Inc. | 2025-02-28 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S001) | Agilent Technologies, Inc. | 2025-02-28 |