Cleared Traditional

BARTELS CYTOMEGALOVIRUS IGM EIA

K922580 · Baxter Diagnostics, Inc. · Microbiology
Apr 1993
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K922580 is an FDA 510(k) clearance for the BARTELS CYTOMEGALOVIRUS IGM EIA, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 8, 1993, 316 days after receiving the submission on May 27, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K922580 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1992
Decision Date April 08, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LKQ — Antibody Igm,if, Cytomegalovirus Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

Similar Devices — LKQ Antibody Igm,if, Cytomegalovirus Virus

All 17
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
K100433 · Siemens Healthcare Diagnostics · May 2010
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · Boston Biomedica, Inc. · Aug 1997
VIDAS CMV IGM ASSAY
K933549 · Biomerieux Vitek, Inc. · Aug 1994
ELISA CMV IGM
K914789 · Sclavo, Inc. · Mar 1992
OPUS(R) ANTI CMV-M
K913080 · Pb Diagnostics, Inc. · Oct 1991
CMV-IGM IFA TEST SYSTEM
K900743 · Zeus Scientific, Inc. · Apr 1990