VYSIS AUTOVYSION SYSTEM
FDA 510(k) clearance DEN040010 · decided 2004-12-13
Clearance details
- K-number
- DEN040010
- Device name
- VYSIS AUTOVYSION SYSTEM
- Applicant
- Vysis
- Decision
- Unknown
- Date received
- 2004-10-13
- Decision date
- 2004-12-13
- Days to decision
- 61 days
- Clearance type
- Post-NSE
- Product code
- NTH
- Device class
- 2
- Regulation number
- 866.4700
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Downers Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.