Cleared Traditional

SERAQUEST MUMPS IGG

K980059 · Quest Intl., Inc. · Microbiology
Apr 1998
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K980059 is an FDA 510(k) clearance for the SERAQUEST MUMPS IGG, a Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I — General Controls, product code LJY), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on April 23, 1998, 106 days after receiving the submission on January 7, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K980059 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1998
Decision Date April 23, 1998
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3380

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