ASPERGILLUS MYCELIAL ANTIGEN #CF10024X— 510(k) K791387

Name: FDA 510(k) clearance K791387
Creator: U.S. Food and Drug Administration
Published: 1979-08-16

Substantially Equivalent

Immuno-Mycologics, Inc.

FDA 510(k) clearance K791387 for ASPERGILLUS MYCELIAL ANTIGEN #CF10024X, Substantially Equivalent on 1979-08-16. Applicant: Immuno-Mycologics, Inc.. Device class: 1.

Clearance details

Applicant: Immuno-Mycologics, Inc.
Product code: Code JWT
Device class: Class 1
Regulation: 21 CFR 866.3040
Advisory panel: Microbiology
Date received: 1979-07-11
Decision date: 1979-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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