LSC · Neisseria Controls
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LSC |
|---|---|
| Device Name | Neisseria Controls |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840506 | HAEMOPHILUS INFLUENZAE TYPE B | Scientific Device Laboratory, Inc. | Apr 4, 1984 | SESE |
| K840514 | NEISSERIA MENINGITIDIS CONTROL | Scientific Device Laboratory, Inc. | Mar 23, 1984 | SESE |
| K840510 | NEISSERIA MENINGITIDIS GR. A | Scientific Device Laboratory, Inc. | Mar 23, 1984 | SESE |
| K840509 | NEISSERIA MENINGITIDIS GR. B | Scientific Device Laboratory, Inc. | Mar 23, 1984 | SESE |
| K840507 | NEISSERIA MENINGITIDIS GR. Y | Scientific Device Laboratory, Inc. | Mar 23, 1984 | SESE |
| K840505 | SDL NEISSERIA MENNINGITIDIS GR. X | Scientific Device Laboratory, Inc. | Mar 23, 1984 | SESE |
| K840504 | SDL NEISSERIA MENINGITIDES GR. 2 | Scientific Device Laboratory, Inc. | Mar 23, 1984 | SESE |
Top Applicants
- Scientific Device Laboratory, Inc. — 7 clearances
