DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS— 510(k) K896926

Name: FDA 510(k) clearance K896926
Creator: U.S. Food and Drug Administration
Published: 1990-01-26

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K896926 for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS, Substantially Equivalent on 1990-01-26. Applicant: Quidel Corp.. Device class: 2.

Clearance details

Applicant: Quidel Corp.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1989-12-11
Decision date: 1990-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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