Atlas FDA

LKQ

18 FDA 510(k) clearances · Product code

109 daysmedian time to decision
316 days90th percentile
18clearances measured

FDA profile

Official device name
Antibody Igm,If, Cytomegalovirus Virus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3175
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2011: 5 · 2016: 29 · 2017: 14 · 2021: 68 · 2022: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, (K100433)Siemens Healthcare Diagnostics2010-05-13
ACCURUN 146 CMV IGM POSITIVE CONTROL (K972884)Boston Biomedica, Inc.1997-08-22
VIDAS CMV IGM ASSAY (K933549)Biomerieux Vitek, Inc.1994-08-02
BARTELS CYTOMEGALOVIRUS IGM EIA (K922580)Baxter Diagnostics, Inc.1993-04-08
ELISA CMV IGM (K914789)Sclavo, Inc.1992-03-04
OPUS(R) ANTI CMV-M (K913080)Pb Diagnostics, Inc.1991-10-28
CMV-IGM IFA TEST SYSTEM (K900743)Zeus Scientific, Inc.1990-04-26
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893465)Immuno Concepts, Inc.1989-07-25
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (K893466)Immuno Concepts, Inc.1989-07-14
ABBOTT CMV-M EIA KIT (K872881)Abbott Laboratories1988-05-13
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (K872942)Clinical Sciences, Inc.1988-01-11
CMV IGM MICROASSAY (K871832)Diamedix Corp.1987-08-07
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES (K863798)Whittaker Bioproducts, Inc.1987-04-14
ENZYGNOST ANTI-CMV IGM TEST (K861363)Behring Diagnostics, Inc.1986-07-21
THE CMV-IGM TEST (K860450)Microbiological Research Corp.1986-05-13
CORDIA CMV-M (K853889)Cordis Corp.1986-04-21
CYTOMEGELISA M TEST KIT (K854839)Whittaker Bioproducts, Inc.1986-02-04
CMV IGM TEST (K831711)Gull Laboratories, Inc.1983-10-27

Track LKQ automatically

Every clearance here is in the API, with alerts when new ones post.