RA-80 POSITIVE CONTROL— 510(k) K813309

Substantially Equivalent

Sun-Kit

FDA 510(k) clearance K813309 for RA-80 POSITIVE CONTROL, Substantially Equivalent on 1981-12-17. Applicant: Sun-Kit. Device class: 2.

Clearance details

Applicant: Sun-Kit
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1981-11-24
Decision date: 1981-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.