QUIDEL HCG ENZYME IMMUNOASSAY KIT— 510(k) K833156

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K833156 for QUIDEL HCG ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1983-11-25. Applicant: Quidel Corp.. Device class: 2.

Clearance details

Applicant: Quidel Corp.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-09-16
Decision date: 1983-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.