Cleared Traditional

CHAGAS' IGG ELISA TEST

K911233 · Gull Laboratories, Inc. · Microbiology
May 1992
Decision
411d
Days
Class 1
Risk

About This 510(k) Submission

K911233 is an FDA 510(k) clearance for the CHAGAS' IGG ELISA TEST, a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I — General Controls, product code MIU), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 4, 1992, 411 days after receiving the submission on March 20, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number K911233 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1991
Decision Date May 04, 1992
Days to Decision 411 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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