FDA product code LIJ: Peroxidase Anti-Peroxidase Immunohistochemical Stain
LIJ is the FDA product code for peroxidase anti-peroxidase immunohistochemical stain. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under LIJ, from 2 different applicants. The average 510(k) review took 120 days (median 120).
Classification
| Field | Value |
|---|---|
| Device name | Peroxidase Anti-Peroxidase Immunohistochemical Stain |
| Device class | Class I |
| Regulation | 21 CFR 864.4400 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LIJ clearance
Top LIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bartels Immunodiagnostic Supplies, Inc. | 1 | 1986-03-11 |
| Dako Corp. | 1 | 1982-07-13 |
Most recent LIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K855034 | Bartels Immunodiagnostic Supplies, Inc. | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | 1986-03-11 | 84 |
| K820336 | Dako Corp. | DAKO PAP KIT K509 | 1982-07-13 | 155 |
Recalls for LIJ devices
openFDA lists no recalls for product code LIJ.
Frequently asked questions
What is FDA product code LIJ?
LIJ is the FDA product code for peroxidase anti-peroxidase immunohistochemical stain. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel.
What device class is LIJ?
Class I, regulation 21 CFR 864.4400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LIJ?
Across 2 cleared submissions the average was 120 days from receipt to decision (median 120).
Which companies have the most LIJ clearances?
Bartels Immunodiagnostic Supplies, Inc. (1); Dako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LIJ
- Run a recall and safety report across every LIJ manufacturer
- Watch product code LIJ 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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