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

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

21 CFR 866.3300 / Microbiology
FDA source (opens on fda.gov)

LHL is the FDA product code for Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a class II device type, regulated under 21 CFR 866.3300. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
LHL
Device name
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
3

Clearances, product code LHL

By decision year
18 clearances under product code LHL with a decision year between 1981 and 1999, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LHL by decision year
YearClearances
19813
19821
19835
19841
19852
19872
19921
19972
19991

Applicants with the most clearances

Product code LHL
Applicants holding the most 510(k) clearances under product code LHL
ApplicantClearances
Biodan Medical Systems, Ltd.2
Bionetic Laboratory Products2
Centers for Disease Control and Prevention2
Genetic Systems Corp.2
Medical Diagnostic Technologies, Inc.2
Zeus Scientific LLC2
Zeus Technologies2
Armkel, LLC1
E.I. Dupont de Nemours & Co., Inc.1
Pro-Lab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code