DRYSPOT INFECTIOUS MONONUCLEOSIS KIT— 510(k) K982634

Name: FDA 510(k) clearance K982634
Creator: U.S. Food and Drug Administration
Published: 1999-01-28

Substantially Equivalent

Oxoid , Ltd.

FDA 510(k) clearance K982634 for DRYSPOT INFECTIOUS MONONUCLEOSIS KIT, Substantially Equivalent on 1999-01-28. Applicant: Oxoid , Ltd.. Device class: 2.

Clearance details

Applicant: Oxoid , Ltd.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1998-07-28
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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