FDA product code LSC: Neisseria Controls
LSC is the FDA product code for neisseria controls. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 7 510(k) submissions under LSC. The average 510(k) review took 48 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Neisseria Controls |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top LSC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Device Laboratory, Inc. | 7 | 1984-04-04 |
Most recent LSC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840506 | Scientific Device Laboratory, Inc. | HAEMOPHILUS INFLUENZAE TYPE B | 1984-04-04 | 58 |
| K840509 | Scientific Device Laboratory, Inc. | NEISSERIA MENINGITIDIS GR. B | 1984-03-23 | 46 |
| K840514 | Scientific Device Laboratory, Inc. | NEISSERIA MENINGITIDIS CONTROL | 1984-03-23 | 46 |
| K840510 | Scientific Device Laboratory, Inc. | NEISSERIA MENINGITIDIS GR. A | 1984-03-23 | 46 |
| K840507 | Scientific Device Laboratory, Inc. | NEISSERIA MENINGITIDIS GR. Y | 1984-03-23 | 46 |
Recalls for LSC devices
openFDA lists no recalls for product code LSC.
Frequently asked questions
What is FDA product code LSC?
LSC is the FDA product code for neisseria controls. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LSC?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LSC?
Across 7 cleared submissions the average was 48 days from receipt to decision (median 46).
Which companies have the most LSC clearances?
Scientific Device Laboratory, Inc. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code LSC
- Run a recall and safety report across every LSC manufacturer
- Watch product code LSC 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.