LJGClass I
Quality Control Slides
21 CFR 866.2660 / Microbiology
LJG is the FDA product code for Quality Control Slides, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- LJG
- Device name
- Quality Control Slides
- Regulation
- 21 CFR 866.2660
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 27
- Ingested recalls
- 5
Clearances, product code LJG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 3 |
| 1988 | 14 |
| 1989 | 3 |
| 1993 | 1 |
| 1994 | 1 |
Applicants with the most clearances
Product code LJG| Applicant | Clearances |
|---|---|
| Sigma Diagnostics, Inc. | 7 |
| Scientific Device Laboratory, Inc. | 6 |
| Val Tech Diagnostics, Inc. | 6 |
| Alpha-Tec Systems, Inc. | 4 |
| Bion Ent., Ltd. | 1 |
| Lab Ability, Inc. | 1 |
| Medastat Scientific Corp. | 1 |
| Meridian Diagnostics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
