Cleared Traditional

HEMAGEN CHAGAS' KIT (EIA METHOD)

K930272 · Hemagen Diagnostics, Inc. · Microbiology
May 1995
Decision
850d
Days
Class 1
Risk

About This 510(k) Submission

K930272 is an FDA 510(k) clearance for the HEMAGEN CHAGAS' KIT (EIA METHOD), a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I — General Controls, product code MIU), submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on May 19, 1995, 850 days after receiving the submission on January 19, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number K930272 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1993
Decision Date May 19, 1995
Days to Decision 850 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3870

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