VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
FDA 510(k) clearance DEN130010 · decided 2013-07-29
Clearance details
- K-number
- DEN130010
- Device name
- VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
- Applicant
- Abbott Molecular, Inc.
- Decision
- Unknown
- Date received
- 2013-04-09
- Decision date
- 2013-07-29
- Days to decision
- 111 days
- Clearance type
- Post-NSE
- Product code
- PDO
- Device class
- 2
- Regulation number
- 864.1870
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| Alinity m HR HPV (P230003/S009) | Abbott Molecular, Inc. | 2025-10-17 |
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| Alinity m HR HPV (P230003/S008) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HBV (P200013/S026) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HR HPV (P230003/S006) | Abbott Molecular, Inc. | 2025-09-10 |
| Vysis CLL Fish Probe Kit (P150041/S007) | Abbott Molecular, Inc. | 2025-08-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S022) | Abbott Molecular, Inc. | 2025-08-05 |
| Alinity m HR HPV (P230003/S007) | Abbott Molecular, Inc. | 2025-04-18 |