VIRGO(TM) RUBELLA IGG ELISA— 510(k) K873088

Name: FDA 510(k) clearance K873088
Creator: U.S. Food and Drug Administration
Published: 1987-09-09

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K873088 for VIRGO(TM) RUBELLA IGG ELISA, Substantially Equivalent on 1987-09-09. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1987-08-05
Decision date: 1987-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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