FDA product code LQH: Dna-Reagents, Legionella
LQH is the FDA product code for dna-reagents, legionella. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under LQH, from 2 different applicants. The average 510(k) review took 122 days (median 122).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Legionella |
| Device class | Class II |
| Regulation | 21 CFR 866.3300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LQH clearance
Top LQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson & CO | 1 | 2004-03-09 |
| Gen-Probe, Inc. | 1 | 1986-07-16 |
Most recent LQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033861 | Becton, Dickinson & CO | BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY | 2004-03-09 | 88 |
| K860498 | Gen-Probe, Inc. | GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM | 1986-07-16 | 156 |
Recalls for LQH devices
openFDA lists no recalls for product code LQH.
Frequently asked questions
What is FDA product code LQH?
LQH is the FDA product code for dna-reagents, legionella. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel.
What device class is LQH?
Class II, regulation 21 CFR 866.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQH?
Across 2 cleared submissions the average was 122 days from receipt to decision (median 122).
Which companies have the most LQH clearances?
Becton, Dickinson & CO (1); Gen-Probe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQH
- Run a recall and safety report across every LQH manufacturer
- Watch product code LQH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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