EMIT C-REACTIVE PROTEIN ASSAY— 510(k) K821413
Substantially EquivalentSyva Co.
FDA 510(k) clearance K821413 for EMIT C-REACTIVE PROTEIN ASSAY, Substantially Equivalent on 1982-05-28. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- 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.