Cleared Traditional

MUMPS IGG ELISA TEST SYSTEM

K991274 · Columbia Bioscience, Inc. · Microbiology
Sep 1999
Decision
143d
Days
Class 1
Risk

About This 510(k) Submission

K991274 is an FDA 510(k) clearance for the MUMPS IGG ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I — General Controls, product code LJY), submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on September 3, 1999, 143 days after receiving the submission on April 13, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K991274 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1999
Decision Date September 03, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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