Cleared Traditional

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4

K903047 · General Biometrics, Inc. · Immunology
Aug 1990
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K903047 is an FDA 510(k) clearance for the IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4, 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 August 9, 1990, 29 days after receiving the submission on July 11, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K903047 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1990
Decision Date August 09, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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