VIRGO (R) CMV-IGG ELISA— 510(k) K883102

Name: FDA 510(k) clearance K883102
Creator: U.S. Food and Drug Administration
Published: 1989-02-08

Substantially Equivalent

Electro-Nucleonics, Inc.

FDA 510(k) clearance K883102 for VIRGO (R) CMV-IGG ELISA, Substantially Equivalent on 1989-02-08. Applicant: Electro-Nucleonics, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1988-07-22
Decision date: 1989-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQI

view all

K951800 — CMV IGG HUMAN SERUM CONTROLS1995-11-16
K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS1995-11-16
K942171 — CMV EARLY ANTIGEN TEST1994-06-30
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST1988-05-06
K863488 — ENZYGNOST ANTI-CMV IGG TEST1987-07-20

More clearances from Electro-Nucleonics, Inc.

view all

K893718 — DELTATEST (R) LIPASE II1989-09-28
K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI1989-04-28
K883281 — VIRGO HSV-2 IGG ELISA1989-03-10
K883282 — VIRGO HSV-1 IGG ELISA1989-03-10
K883427 — VIRGO(R) VZV-IGG ELISA1989-03-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.