AUTOMATIC ELISA READER— 510(k) K811111

Substantially Equivalent

Artek Systems Corp.

FDA 510(k) clearance K811111 for AUTOMATIC ELISA READER, Substantially Equivalent on 1981-05-08. Applicant: Artek Systems Corp.. Device class: 1.

Clearance details

Applicant: Artek Systems Corp.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1981-04-23
Decision date: 1981-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.