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

Latex Agglutination Assay, Rubella

21 CFR 866.3510 / Microbiology
FDA source (opens on fda.gov)

LQN is the FDA product code for Latex Agglutination Assay, Rubella, a class II device type, regulated under 21 CFR 866.3510. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LQN
Device name
Latex Agglutination Assay, Rubella
Regulation
21 CFR 866.3510
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
13
Ingested recalls
0

Clearances, product code LQN

By decision year
13 clearances under product code LQN with a decision year between 1985 and 2003, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LQN by decision year
YearClearances
19852
19862
19892
19901
19921
19963
19971
20031

Applicants with the most clearances

Product code LQN
Applicants holding the most 510(k) clearances under product code LQN
ApplicantClearances
Orion Corp.4
Armkel, LLC2
Biokit USA, Inc.2
Sienna Biotech, Inc.2
Immunostics, Inc.1
Murex Diagnostics, Inc.1
Seradyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code