VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
FDA 510(k) clearance K091960 · decided 2011-08-29
Clearance details
- K-number
- K091960
- Device name
- VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
- Applicant
- Abbott Molecular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-01
- Decision date
- 2011-08-29
- Days to decision
- 789 days
- Clearance type
- Traditional
- Product code
- OWK
- Device class
- 2
- Regulation number
- 866.6040
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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/S015) | Abbott Molecular, Inc. | 2026-07-23 |
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| Alinity m HR HPV (P230003/S016) | Abbott Molecular, Inc. | 2026-05-19 |
| Alinity m HR HPV (P230003/S013) | Abbott Molecular, Inc. | 2026-05-15 |