HISTOPLASMA CAPSULATUM, ANTIGEN YEAST— 510(k) K792704

Name: FDA 510(k) clearance K792704
Creator: U.S. Food and Drug Administration
Published: 1980-01-17

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K792704 for HISTOPLASMA CAPSULATUM, ANTIGEN YEAST, Substantially Equivalent on 1980-01-17. Applicant: Meridian Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code GMJ
Device class: Class 2
Regulation: 21 CFR 866.3320
Advisory panel: Microbiology
Date received: 1979-12-27
Decision date: 1980-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K792701 — HISTOPLASMA CAPSULATUM, ANTIGEN1980-01-23
K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE1980-01-17

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