Cleared Traditional

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE

K930247 · The Binding Site, Ltd. · Immunology
Mar 1993
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K930247 is an FDA 510(k) clearance for the HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE, a System, Test, Systemic Lupus Erythematosus (Class II — Special Controls, product code DHC), submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 10, 1993, 50 days after receiving the submission on January 19, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K930247 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1993
Decision Date March 10, 1993
Days to Decision 50 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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