Cleared Traditional

OPUS CMV-G

K933389 · Pb Diagnostic Systems, Inc. · Microbiology
Jun 1994
Decision
351d
Days
Class 2
Risk

About This 510(k) Submission

K933389 is an FDA 510(k) clearance for the OPUS CMV-G, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on June 28, 1994, 351 days after receiving the submission on July 12, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K933389 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1993
Decision Date June 28, 1994
Days to Decision 351 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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