ALPHA CRYPTOCOCCAL ANTIGEN EIA— 510(k) K120946

Name: FDA 510(k) clearance K120946
Creator: U.S. Food and Drug Administration
Published: 2012-12-17

Substantially Equivalent

Immuno-Mycologics, Inc.

FDA 510(k) clearance K120946 for ALPHA CRYPTOCOCCAL ANTIGEN EIA, Substantially Equivalent on 2012-12-17. Applicant: Immuno-Mycologics, Inc.. Device class: 2.

Clearance details

Applicant: Immuno-Mycologics, Inc.
Product code: Code MDU
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 2012-03-29
Decision date: 2012-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norman, OK, US

Download summary PDF View on FDA.gov ↗

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