ACCULEVEL PHENYTOIN TEST— 510(k) K855026
Substantially EquivalentSyva / A Syntex Co.
FDA 510(k) clearance K855026 for ACCULEVEL PHENYTOIN TEST, Substantially Equivalent on 1986-08-25. Applicant: Syva / A Syntex Co.. Device class: 2.
Clearance details
- Applicant
- Syva / A Syntex Co.
- Product code
- Code DIP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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More clearances from Syva / A Syntex Co.
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