IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST— 510(k) K922296

Name: FDA 510(k) clearance K922296
Creator: U.S. Food and Drug Administration
Published: 1992-07-14

Substantially Equivalent

Ampcor, Inc.

FDA 510(k) clearance K922296 for IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST, Substantially Equivalent on 1992-07-14. Applicant: Ampcor, Inc.. Device class: 2.

Clearance details

Applicant: Ampcor, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1992-05-15
Decision date: 1992-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

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