ENZYGNOST ANTI-VZV IGG TEST— 510(k) K863317

Name: FDA 510(k) clearance K863317
Creator: U.S. Food and Drug Administration
Published: 1987-04-22

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K863317 for ENZYGNOST ANTI-VZV IGG TEST, Substantially Equivalent on 1987-04-22. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GQX
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1986-08-26
Decision date: 1987-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, 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
K883427 — VIRGO(R) VZV-IGG ELISA1989-03-10
K875358 — VZV TEST1988-03-31
K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY1986-02-04

More clearances from Behring Diagnostics, Inc.

view all

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972316 — OPUS D-DIMER1997-09-09

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