QMS TM- PHENYTOIN
FDA 510(k) clearance K904815 · decided 1990-11-06
Clearance details
- K-number
- K904815
- Device name
- QMS TM- PHENYTOIN
- Applicant
- Seradyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-24
- Decision date
- 1990-11-06
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- DIP
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.