Cleared Traditional

SERAQUEST ANTI-SSA

K980810 · Quest Intl., Inc. · Immunology
May 1998
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K980810 is an FDA 510(k) clearance for the SERAQUEST ANTI-SSA, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on May 12, 1998, 70 days after receiving the submission on March 3, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K980810 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1998
Decision Date May 12, 1998
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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