THE INTUITIVE COLORIMETER
FDA 510(k) clearance K012298 · decided 2001-09-26
Clearance details
- K-number
- K012298
- Device name
- THE INTUITIVE COLORIMETER
- Applicant
- Cerium Optical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-20
- Decision date
- 2001-09-26
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- NFD
- Device class
- 1
- Regulation number
- 886.1160
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.