GSC 1000— 510(k) K863566

Substantially Equivalent

Genetic Systems Corp.

FDA 510(k) clearance K863566 for GSC 1000, Substantially Equivalent on 1986-10-16. Applicant: Genetic Systems Corp.. Device class: 1.

Clearance details

Applicant: Genetic Systems Corp.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1986-09-12
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.