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

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..

Clearance details

Applicant
Quidel Corp.
Product code
Code KTN
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
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