FDA product code KJK: Auramine O
KJK is the FDA product code for auramine o. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under KJK, from 2 different applicants. The average 510(k) review took 20 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Auramine O |
| 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 KJK clearance
Top KJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Medical Technology, Inc. | 1 | 1985-08-13 |
| Carr-Scarborough Microbiologicals, Inc. | 1 | 1981-09-01 |
Most recent KJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853081 | Advanced Medical Technology, Inc. | AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET | 1985-08-13 | 21 |
| K812274 | Carr-Scarborough Microbiologicals, Inc. | AURAMINE O MYCROBACTERIAL STAIN SET | 1981-09-01 | 19 |
Recalls for KJK devices
openFDA lists no recalls for product code KJK.
Frequently asked questions
What is FDA product code KJK?
KJK is the FDA product code for auramine o. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJK?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJK?
Across 2 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most KJK clearances?
Advanced Medical Technology, Inc. (1); Carr-Scarborough Microbiologicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJK
- Run a recall and safety report across every KJK manufacturer
- Watch product code KJK 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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