LJG · Quality Control Slides
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LJG |
|---|---|
| Device Name | Quality Control Slides |
| 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 (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943228 | MICROSPORIDIUM CONTROL SET | Meridian Diagnostics, Inc. | Oct 27, 1994 | SESE |
| K924893 | MICROSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | Jan 15, 1993 | SESE |
| K890718 | GRAM STAIN CONTROL SLIDE | Scientific Device Laboratory, Inc. | Mar 16, 1989 | SESE |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | Mar 16, 1989 | SESE |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | Bion Ent., Ltd. | Feb 17, 1989 | SESE |
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | Val Tech Diagnostics, Inc. | Oct 6, 1988 | SESE |
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | Val Tech Diagnostics, Inc. | Oct 6, 1988 | SESE |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | Val Tech Diagnostics, Inc. | Oct 6, 1988 | SESE |
| K883568 | HISTO-CHECK ACID FAST SLIDES | Val Tech Diagnostics, Inc. | Oct 6, 1988 | SESE |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | Val Tech Diagnostics, Inc. | Oct 6, 1988 | SESE |
| K883208 | HISTO-CHECK SLIDES | Val Tech Diagnostics, Inc. | Aug 25, 1988 | SESE |
| K881112 | FUNGI HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | Apr 21, 1988 | SESE |
| K881109 | SPIROCHETES HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | Apr 21, 1988 | SESE |
| K881106 | ACID FAST BACILLI HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | Apr 21, 1988 | SESE |
| K881110 | LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | Apr 12, 1988 | SESE |
| K881108 | PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | Apr 12, 1988 | SESE |
| K881111 | INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL | Sigma Diagnostics, Inc. | Mar 30, 1988 | SESE |
| K881107 | INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | Mar 30, 1988 | SESE |
| K880962 | ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES | Alpha-Tec Systems, Inc. | Mar 30, 1988 | SESE |
| K840517 | PROTOZOA STAIN CONTROL | Scientific Device Laboratory, Inc. | Mar 9, 1984 | SESE |
Top Applicants
- Sigma Diagnostics, Inc. — 7 clearances
- Scientific Device Laboratory, Inc. — 6 clearances
- Val Tech Diagnostics, Inc. — 6 clearances
- Alpha-Tec Systems, Inc. — 4 clearances
- Bion Ent., Ltd. — 1 clearance
