Cleared Traditional

ENZYGNOST ANTI-CMV IGG TEST

K863488 · Behring Diagnostics, Inc. · Microbiology
Jul 1987
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K863488 is an FDA 510(k) clearance for the ENZYGNOST ANTI-CMV IGG TEST, a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI), submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on July 20, 1987, 314 days after receiving the submission on September 9, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K863488 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date July 20, 1987
Days to Decision 314 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQI — Antiserum, Cf, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

Similar Devices — GQI Antiserum, Cf, Cytomegalovirus

All 17
CMV IGG HUMAN SERUM CONTROLS
K951800 · Pyramid Biological Corp. · Nov 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · Pyramid Biological Corp. · Nov 1995
CMV EARLY ANTIGEN TEST
K942171 · Neogenex · Jun 1994
VIRGO (R) CMV-IGG ELISA
K883102 · Electro-Nucleonics, Inc. · Feb 1989
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · Gull Laboratories, Inc. · May 1988
THE GOLDEN QUAD TEST (CMV)
K861123 · Microbiological Research Corp. · Feb 1987