VIRGO(R) VZV-IGG ELISA— 510(k) K883427

Name: FDA 510(k) clearance K883427
Creator: U.S. Food and Drug Administration
Published: 1989-03-10

Substantially Equivalent

Electro-Nucleonics, Inc.

FDA 510(k) clearance K883427 for VIRGO(R) VZV-IGG ELISA, Substantially Equivalent on 1989-03-10. Applicant: Electro-Nucleonics, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics, Inc.
Product code: Code GQX
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1988-08-15
Decision date: 1989-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQX

view all

K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY1996-03-20
K911301 — VZV IGM TEST1991-07-17
K875358 — VZV TEST1988-03-31
K863317 — ENZYGNOST ANTI-VZV IGG TEST1987-04-22
K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY1986-02-04

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
K883102 — VIRGO (R) CMV-IGG ELISA1989-02-08

Recalls naming K883427

K-number listed on FDA's recall record

Z-2445-2012 — Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.Class III·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·20120529

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K883427.

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