EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY— 510(k) K811034
Substantially EquivalentSyva Co.
FDA 510(k) clearance K811034 for EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY, Substantially Equivalent on 1981-05-01. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code LAR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.