Cleared Traditional

SERAQUEST ANTI-SSB

K980639 · Quest Intl., Inc. · Immunology
Jun 1998
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K980639 is an FDA 510(k) clearance for the SERAQUEST ANTI-SSB, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on June 15, 1998, 116 days after receiving the submission on February 19, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K980639 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1998
Decision Date June 15, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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