Cleared Traditional

IMMUNOWELL DSDNA ANTIBODY TEST

K914801 · General Biometrics, Inc. · Immunology
Dec 1991
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K914801 is an FDA 510(k) clearance for the IMMUNOWELL DSDNA ANTIBODY TEST, a System, Test, Systemic Lupus Erythematosus (Class II — Special Controls, product code DHC), submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1991, 46 days after receiving the submission on October 24, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K914801 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1991
Decision Date December 09, 1991
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DHC — System, Test, Systemic Lupus Erythematosus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5820

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