SLE ANTI-N-DNA LATEX TEST— 510(k) K810226

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K810226 for SLE ANTI-N-DNA LATEX TEST, Substantially Equivalent on 1981-02-09. Applicant: Icl Scientific. Device class: 2.

Clearance details

Applicant: Icl Scientific
Product code: Code DHC
Device class: Class 2
Regulation: 21 CFR 866.5820
Advisory panel: Immunology
Date received: 1981-01-27
Decision date: 1981-02-09
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.