Cleared Traditional

IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL

K924843 · General Biometrics, Inc. · Immunology
Dec 1992
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K924843 is an FDA 510(k) clearance for the IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 1, 1992, 64 days after receiving the submission on September 28, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K924843 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1992
Decision Date December 01, 1992
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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