FDA product code LQO: Dna-Reagents, Campylobacter Spp.
LQO is the FDA product code for dna-reagents, campylobacter spp.. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LQO, from 4 different applicants. The average 510(k) review took 209 days (median 191).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Campylobacter Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LQO clearance
Top LQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 1 | 1989-11-14 |
| Molecular Biosystems, Inc. | 1 | 1988-06-08 |
| Wampole Laboratories | 1 | 1988-03-01 |
| Integrated Genetics | 1 | 1987-08-31 |
Most recent LQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894712 | Gen-Probe, Inc. | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION | 1989-11-14 | 111 |
| K873670 | Molecular Biosystems, Inc. | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT | 1988-06-08 | 271 |
| K875101 | Wampole Laboratories | VIROGEN CMV ANTIBODY TEST | 1988-03-01 | 82 |
| K863270 | Integrated Genetics | GENE-TRAK CAMPYLOBACTER ASSAY | 1987-08-31 | 371 |
Recalls for LQO devices
openFDA lists no recalls for product code LQO.
Frequently asked questions
What is FDA product code LQO?
LQO is the FDA product code for dna-reagents, campylobacter spp.. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is LQO?
Class I, regulation 21 CFR 866.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQO?
Across 4 cleared submissions the average was 209 days from receipt to decision (median 191).
Which companies have the most LQO clearances?
Gen-Probe, Inc. (1); Molecular Biosystems, Inc. (1); Wampole Laboratories (1); Integrated Genetics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQO
- Run a recall and safety report across every LQO manufacturer
- Watch product code LQO 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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