DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST— 510(k) K893737

Name: FDA 510(k) clearance K893737
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K893737 for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST, Substantially Equivalent on 1989-06-16. 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: 1989-05-17
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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