LA-HISTO ANTIBODY SYSTEM #HL 1001— 510(k) K830837

Name: FDA 510(k) clearance K830837
Creator: U.S. Food and Drug Administration
Published: 1983-05-05

Substantially Equivalent

Immuno-Mycologics, Inc.

FDA 510(k) clearance K830837 for LA-HISTO ANTIBODY SYSTEM #HL 1001, Substantially Equivalent on 1983-05-05. 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: 1983-03-16
Decision date: 1983-05-05
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
K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE1980-01-17

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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 K830837

K-number listed on FDA's recall record

Z-2301-2020 — Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID AntigenClass II·Terminated·Immuno-Mycologics, Inc·20191104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K830837.

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