Cleared Traditional

K101407 - ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
(FDA 510(k) Clearance)

K101407 · Immuno-Mycologics, Inc. · Microbiology
Jul 2011
Decision
426d
Days
Class 2
Risk

K101407 is an FDA 510(k) clearance for the ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum (Class II — Special Controls, product code MIZ).

Submitted by Immuno-Mycologics, Inc. (Norman, US). The FDA issued a Cleared decision on July 19, 2011, 426 days after receiving the submission on May 19, 2010.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3320.

Submission Details

510(k) Number K101407 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2010
Decision Date July 19, 2011
Days to Decision 426 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MIZ — Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3320