Cleared Traditional

VIRGO(TM) MEASLES IGG ELISA

K873925 · Electro-Nucleonics Laboratories, Inc. · Microbiology

Feb 1988

Decision

152d

Days

Class 1

Risk

About This 510(k) Submission

K873925 is an FDA 510(k) clearance for the VIRGO(TM) MEASLES IGG ELISA, a Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I — General Controls, product code LJB), submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on February 24, 1988, 152 days after receiving the submission on September 25, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3520.

Submission Details

510(k) Number	K873925 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 1987
Decision Date	February 24, 1988
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

Device Classification

Product Code	LJB — Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3520
Definition	The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma.