STRATUS PHENYTOIN FLUOROMETRIC ENZYME— 510(k) K831154
Substantially EquivalentAmerican Dade
FDA 510(k) clearance K831154 for STRATUS PHENYTOIN FLUOROMETRIC ENZYME, Substantially Equivalent on 1983-05-16. Applicant: American Dade.
Clearance details
- Applicant
- American Dade
- Product code
- Code LES
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.