510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LKQClass II

Antibody Igm,If, Cytomegalovirus Virus

21 CFR 866.3175 / Microbiology
FDA source (opens on fda.gov)

LKQ is the FDA product code for Antibody Igm,If, Cytomegalovirus Virus, a class II device type, regulated under 21 CFR 866.3175. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
LKQ
Device name
Antibody Igm,If, Cytomegalovirus Virus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
18
Ingested recalls
8

Clearances, product code LKQ

By decision year
18 clearances under product code LKQ with a decision year between 1983 and 2010, 1986 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LKQ by decision year
YearClearances
19831
19864
19872
19882
19892
19901
19911
19921
19931
19941
19971
20101

Applicants with the most clearances

Product code LKQ
Applicants holding the most 510(k) clearances under product code LKQ
ApplicantClearances
IMMUNO CONCEPTS, NA, Ltd.2
Whittaker Bioproducts, Inc.2
Abbott Medical1
Baxter Diagnostics, Inc.1
Behring Diagnostics, Inc.1
Biomerieux Vitek, Inc.1
Boston Biomedica, Inc.1
Clinical Sciences, Inc.1
Cordis US Corp.1
Diamedix Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code