HISTOPLASMA YEAST ANTI #CF10021X— 510(k) K791393

Name: FDA 510(k) clearance K791393
Creator: U.S. Food and Drug Administration
Published: 1979-08-16

Substantially Equivalent

Immuno-Mycologics, Inc.

FDA 510(k) clearance K791393 for HISTOPLASMA YEAST ANTI #CF10021X, Substantially Equivalent on 1979-08-16. Applicant: Immuno-Mycologics, Inc.. Device class: 2.

Clearance details

Applicant: Immuno-Mycologics, Inc.
Product code: Code GMJ
Device class: Class 2
Regulation: 21 CFR 866.3320
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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K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM1980-09-26
K792701 — HISTOPLASMA CAPSULATUM, ANTIGEN1980-01-23
K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST1980-01-17

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K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA)2011-07-20
K101407 — ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG1022011-07-19
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Recalls naming K791393

K-number listed on FDA's recall record

Z-2040-2016 — Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosisClass II·Terminated·Immuno-Mycologics, Inc·20160509

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K791393.

Data sourced from openFDA. This site is unofficial and independent of the FDA.