Cleared Traditional

ELIAS DSDNA ABS

K930421 · Elias U.S.A., Inc. · Immunology
Mar 1993
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K930421 is an FDA 510(k) clearance for the ELIAS DSDNA ABS, a System, Test, Systemic Lupus Erythematosus (Class II — Special Controls, product code DHC), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on March 10, 1993, 43 days after receiving the submission on January 26, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K930421 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date March 10, 1993
Days to Decision 43 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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