FDA product code LJG: Quality Control Slides
LJG is the FDA product code for quality control slides. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 27 510(k) submissions under LJG, from 8 different applicants. The average 510(k) review took 36 days (median 32). FDA has posted 5 recalls for LJG devices.
Classification
| Field | Value |
|---|---|
| Device name | Quality Control Slides |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LJG clearance
Top LJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 7 | 1988-04-21 |
| Scientific Device Laboratory, Inc. | 6 | 1993-01-15 |
| Val Tech Diagnostics, Inc. | 6 | 1988-10-06 |
| Alpha-Tec Systems, Inc. | 4 | 1988-03-30 |
| Meridian Diagnostics, Inc. | 1 | 1994-10-27 |
3 more applicants have LJG clearances. See the full list in Caduvo.
Most recent LJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943228 | Meridian Diagnostics, Inc. | MICROSPORIDIUM CONTROL SET | 1994-10-27 | 113 |
| K924893 | Scientific Device Laboratory, Inc. | MICROSPORIDIUM CONTROL SLIDE | 1993-01-15 | 109 |
| K890718 | Scientific Device Laboratory, Inc. | GRAM STAIN CONTROL SLIDE | 1989-03-16 | 31 |
| K890670 | Scientific Device Laboratory, Inc. | CRYPTOSPORIDIUM CONTROL SLIDE | 1989-03-16 | 35 |
| K890616 | Bion Ent., Ltd. | BION DIRECT IDENTIFICATION CONTROL SLIDE | 1989-02-17 | 10 |
Recalls for LJG devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-03-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code LJG?
LJG is the FDA product code for quality control slides. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LJG?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJG?
Across 27 cleared submissions the average was 36 days from receipt to decision (median 32).
Which companies have the most LJG clearances?
Sigma Diagnostics, Inc. (7); Scientific Device Laboratory, Inc. (6); Val Tech Diagnostics, Inc. (6); Alpha-Tec Systems, Inc. (4); Meridian Diagnostics, Inc. (1).
Have LJG devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2019-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LJG
- Run a recall and safety report across every LJG manufacturer
- Watch product code LJG 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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