CYTOVISION FOR CEP XY
FDA 510(k) clearance K042542 · decided 2005-01-10
Clearance details
- K-number
- K042542
- Device name
- CYTOVISION FOR CEP XY
- Applicant
- Applied Imaging Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-20
- Decision date
- 2005-01-10
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- NTH
- Device class
- 2
- Regulation number
- 866.4700
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.