Cleared Traditional

ABBOTT CHAGAS ANTIBODY EIA

K933716 · Abbott Laboratories · Microbiology
Dec 1994
Decision
507d
Days
Class 1
Risk

About This 510(k) Submission

K933716 is an FDA 510(k) clearance for the ABBOTT CHAGAS ANTIBODY EIA, a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I — General Controls, product code MIU), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994, 507 days after receiving the submission on July 30, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number K933716 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1993
Decision Date December 19, 1994
Days to Decision 507 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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