FDA product code KJR: Erythrosin B
KJR is the FDA product code for erythrosin b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under KJR, from 2 different applicants. The average 510(k) review took 29 days (median 39).
Classification
| Field | Value |
|---|---|
| Device name | Erythrosin B |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KJR clearance
Top KJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bartels Immunodiagnostic Supplies, Inc. | 2 | 1984-08-28 |
| Alta Diagnostics, Inc. | 1 | 1979-12-18 |
Most recent KJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842834 | Bartels Immunodiagnostic Supplies, Inc. | HEP-2 CELLS | 1984-08-28 | 39 |
| K842833 | Bartels Immunodiagnostic Supplies, Inc. | PMK PRIMARY MONKEY KIDNEY-CELLS | 1984-08-28 | 39 |
| K792546 | Alta Diagnostics, Inc. | FETAL CHECK | 1979-12-18 | 8 |
Recalls for KJR devices
openFDA lists no recalls for product code KJR.
Frequently asked questions
What is FDA product code KJR?
KJR is the FDA product code for erythrosin b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJR?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJR?
Across 3 cleared submissions the average was 29 days from receipt to decision (median 39).
Which companies have the most KJR clearances?
Bartels Immunodiagnostic Supplies, Inc. (2); Alta Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJR
- Run a recall and safety report across every KJR manufacturer
- Watch product code KJR 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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