ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM— 510(k) K972406

Name: FDA 510(k) clearance K972406
Creator: U.S. Food and Drug Administration
Published: 1997-12-22

Substantially Equivalent

Immunoprobe, Inc.

FDA 510(k) clearance K972406 for ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM, Substantially Equivalent on 1997-12-22. Applicant: Immunoprobe, Inc.. Device class: 1.

Clearance details

Applicant: Immunoprobe, Inc.
Product code: Code GOD
Device class: Class 1
Regulation: 21 CFR 866.3020
Advisory panel: Microbiology
Date received: 1997-06-26
Decision date: 1997-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

Download summary PDF View on FDA.gov ↗

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