FDA product code LGJ: Fluorescence Polarization Immunoassay, Amibacin
LGJ is the FDA product code for fluorescence polarization immunoassay, amibacin. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under LGJ, from 3 different applicants. The average 510(k) review took 65 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Amibacin |
| Device class | Class II |
| Regulation | 21 CFR 862.3035 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LGJ clearance
Top LGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 1999-07-22 |
| Roche Diagnostic Systems, Inc. | 1 | 1994-06-13 |
| Windsor Laboratories, Inc. | 1 | 1986-08-04 |
Most recent LGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991597 | Roche Diagnostics Corp. | COBAS INTEGRA AMIKACIN MAB | 1999-07-22 | 73 |
| K941712 | Roche Diagnostic Systems, Inc. | COBAS-FP REAGENTS AND CALIBRATORS | 1994-06-13 | 68 |
| K862248 | Windsor Laboratories, Inc. | AMIKACIN KIT (FPIA) | 1986-08-04 | 53 |
Recalls for LGJ devices
openFDA lists no recalls for product code LGJ.
Frequently asked questions
What is FDA product code LGJ?
LGJ is the FDA product code for fluorescence polarization immunoassay, amibacin. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel.
What device class is LGJ?
Class II, regulation 21 CFR 862.3035. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGJ?
Across 3 cleared submissions the average was 65 days from receipt to decision (median 68).
Which companies have the most LGJ clearances?
Roche Diagnostics Corp. (1); Roche Diagnostic Systems, Inc. (1); Windsor Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGJ
- Run a recall and safety report across every LGJ manufacturer
- Watch product code LGJ 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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