Cleared Traditional

SERAQUEST ANTI-DSDNA

K980391 · Quest Intl., Inc. · Immunology
Apr 1998
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K980391 is an FDA 510(k) clearance for the SERAQUEST ANTI-DSDNA, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on April 24, 1998, 81 days after receiving the submission on February 2, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K980391 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1998
Decision Date April 24, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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