FDA product code JJK: Oncometer, Plasma, For Clinical Use
JJK is the FDA product code for oncometer, plasma, for clinical use. It is a Class I device, regulated under 21 CFR 862.2720 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under JJK, from 4 different applicants. The average 510(k) review took 46 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Oncometer, Plasma, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2720 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJK clearance
Top JJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 1 | 1986-09-16 |
| Boehringer Mannheim Corp. | 1 | 1982-11-29 |
| Nuclear Medical Laboratories, Inc. | 1 | 1980-10-20 |
| Instrumentation Laboratory CO | 1 | 1977-01-12 |
Most recent JJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863099 | Abbott Laboratories | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT | 1986-09-16 | 34 |
| K823196 | Boehringer Mannheim Corp. | SPECIAL CONTROL SERUM FOR HDL-CHOLES | 1982-11-29 | 34 |
| K802120 | Nuclear Medical Laboratories, Inc. | HEPA-SHURE -L | 1980-10-20 | 46 |
| K760975 | Instrumentation Laboratory CO | WEIL ONCOMETER (IL 186) | 1977-01-12 | 70 |
Recalls for JJK devices
openFDA lists no recalls for product code JJK.
Frequently asked questions
What is FDA product code JJK?
JJK is the FDA product code for oncometer, plasma, for clinical use. It is a Class I device, regulated under 21 CFR 862.2720 and reviewed by the Clinical Chemistry panel.
What device class is JJK?
Class I, regulation 21 CFR 862.2720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJK?
Across 4 cleared submissions the average was 46 days from receipt to decision (median 40).
Which companies have the most JJK clearances?
Abbott Laboratories (1); Boehringer Mannheim Corp. (1); Nuclear Medical Laboratories, Inc. (1); Instrumentation Laboratory CO (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JJK
- Run a recall and safety report across every JJK manufacturer
- Watch product code JJK 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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