Cleared Traditional

K873088 - VIRGO(TM) RUBELLA IGG ELISA
(FDA 510(k) Clearance)

K873088 · Electro-Nucleonics Laboratories, Inc. · Microbiology

Sep 1987

Decision

35d

Days

Class 2

Risk

K873088 is an FDA 510(k) clearance for the VIRGO(TM) RUBELLA IGG ELISA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX).

Submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on September 9, 1987, 35 days after receiving the submission on August 5, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K873088 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1987
Decision Date	September 09, 1987
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—