Cleared Traditional

DIAMEDIX IS-CMV IGG TEST SYSTEM

K981163 · Diamedix Corp. · Microbiology
Sep 1998
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K981163 is an FDA 510(k) clearance for the DIAMEDIX IS-CMV IGG TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 21, 1998, 174 days after receiving the submission on March 31, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K981163 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1998
Decision Date September 21, 1998
Days to Decision 174 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

Similar Devices — LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 57
Architect CMV IgG
K220949 · Abbott Laboratories · Oct 2022
Elecsys CMV IgG
K220911 · Roche Diagnostics · Oct 2022
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
Elecsys CMV IgM
K163569 · Roche Diagnostics · Mar 2017
LIAISON? CMV IgG and LIAISON? CMV IgG Serum Control Set
K162969 · DiaSorin, Inc. · Jan 2017
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
K142133 · Roche Diagnostics · Oct 2014