SERA FOR ANTINUCLEAR ANTIBODIES— 510(k) K820945
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K820945 for SERA FOR ANTINUCLEAR ANTIBODIES, Substantially Equivalent on 1982-10-26. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.