CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
FDA 510(k) clearance K954214 · decided 1997-01-21
Clearance details
- K-number
- K954214
- Device name
- CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
- Applicant
- Vysis
- Decision
- Substantially Equivalent
- Date received
- 1995-09-07
- Decision date
- 1997-01-21
- Days to decision
- 502 days
- Clearance type
- Traditional
- Product code
- OXP
- Device class
- 2
- Regulation number
- 866.6010
- 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.