FDA product code LJF: Device, Antimicrobial Drug Removal
LJF is the FDA product code for device, antimicrobial drug removal. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LJF, from 3 different applicants. The average 510(k) review took 46 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Device, Antimicrobial Drug Removal |
| Device class | Class I |
| Regulation | 21 CFR 866.2560 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LJF clearance
Top LJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marion Laboratories, Inc. | 2 | 1983-04-08 |
| Organon Teknika Corp. | 1 | 2000-10-20 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1983-03-24 |
Most recent LJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003104 | Organon Teknika Corp. | BACT/ALERT CSR | 2000-10-20 | 52 |
| K830372 | Marion Laboratories, Inc. | ARTIMICROBIAL REMOVAL DEVICE | 1983-04-08 | 63 |
| K830363 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC 170 TRYPTIC SOY BROTH W/RESINS | 1983-03-24 | 48 |
| K822344 | Marion Laboratories, Inc. | ANTIMICROBIAL REMOVAL DEVICE (ARD) | 1982-08-25 | 20 |
Recalls for LJF devices
openFDA lists no recalls for product code LJF.
Frequently asked questions
What is FDA product code LJF?
LJF is the FDA product code for device, antimicrobial drug removal. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel.
What device class is LJF?
Class I, regulation 21 CFR 866.2560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJF?
Across 4 cleared submissions the average was 46 days from receipt to decision (median 50).
Which companies have the most LJF clearances?
Marion Laboratories, Inc. (2); Organon Teknika Corp. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LJF
- Run a recall and safety report across every LJF manufacturer
- Watch product code LJF 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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