UA PERFECT
FDA 510(k) clearance K935408 · decided 1994-06-13
Clearance details
- K-number
- K935408
- Device name
- UA PERFECT
- Applicant
- Chimera Research & Chemical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-09
- Decision date
- 1994-06-13
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seminole, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.