DART PHENYTOIN
FDA 510(k) clearance K880294 · decided 1988-05-27
Clearance details
- K-number
- K880294
- Device name
- DART PHENYTOIN
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-25
- Decision date
- 1988-05-27
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- LFO
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hialeah, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.