EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL— 510(k) K011947
Substantially EquivalentSyva Co.
FDA 510(k) clearance K011947 for EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL, Substantially Equivalent on 2001-07-02. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code LEG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cupertino, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.