Cleared Traditional

MUMPS IGG ELISA TESTY

K971857 · Gull Laboratories, Inc. · Microbiology
Nov 1997
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K971857 is an FDA 510(k) clearance for the MUMPS IGG ELISA TESTY, a Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I — General Controls, product code LJY), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 4, 1997, 168 days after receiving the submission on May 20, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K971857 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1997
Decision Date November 04, 1997
Days to Decision 168 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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