Cleared Traditional

SERAQUEST RUBELLA IGM

K982281 · Quest Intl., Inc. · Microbiology
Oct 1998
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K982281 is an FDA 510(k) clearance for the SERAQUEST RUBELLA IGM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on October 16, 1998, 108 days after receiving the submission on June 30, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K982281 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1998
Decision Date October 16, 1998
Days to Decision 108 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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