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

Dna-Reagents, Legionella

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

LQH is the FDA product code for Dna-Reagents, Legionella, a class II device type, regulated under 21 CFR 866.3300. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LQH
Device name
Dna-Reagents, Legionella
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
2
Ingested recalls
0

Clearances, product code LQH

By decision year
2 clearances under product code LQH with a decision year between 1986 and 2004, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LQH by decision year
YearClearances
19861
20041

Applicants with the most clearances

Product code LQH
Applicants holding the most 510(k) clearances under product code LQH
ApplicantClearances
Becton Dickinson & Co1
Hologic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code