CYTOMEGALOVIRUS IGG EIA TEST KIT— 510(k) K862705

Name: FDA 510(k) clearance K862705
Creator: U.S. Food and Drug Administration
Published: 1986-10-01

Substantially Equivalent

Labsystems, Inc.

FDA 510(k) clearance K862705 for CYTOMEGALOVIRUS IGG EIA TEST KIT, Substantially Equivalent on 1986-10-01. Applicant: Labsystems, Inc.. Device class: 2.

Clearance details

Applicant: Labsystems, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1986-07-16
Decision date: 1986-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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
K883102 — VIRGO (R) CMV-IGG ELISA1989-02-08
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST1988-05-06

More clearances from Labsystems, Inc.

view all

K923365 — TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM1993-03-24
K896474 — RESUBMITTED FECATWIN SENSITIVE - FECA-EIA1990-01-25
K890154 — MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA1989-02-07
K890091 — MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT1989-02-03
K881243 — RUBELLA IGG - EIA TEST KIT NUMBER 61 07 2011988-04-04

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