FDA product code JLA: Conversion To Creatinine, Creatine
JLA is the FDA product code for conversion to creatinine, creatine. It is a Class I device, regulated under 21 CFR 862.1210 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JLA, from 2 different applicants. The average 510(k) review took 300 days (median 300). FDA has posted 1 recall for JLA devices.
Classification
| Field | Value |
|---|---|
| Device name | Conversion To Creatinine, Creatine |
| Device class | Class I |
| Regulation | 21 CFR 862.1210 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JLA clearance
Top JLA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Panmed, Inc. | 1 | 1986-11-13 |
| American Bioproducts Co. | 1 | 1986-01-03 |
Most recent JLA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852767 | Panmed, Inc. | ERYTHOCYTE CREATINE | 1986-11-13 | 503 |
| K854016 | American Bioproducts Co. | ASSERACHROM PROTEIN C KIT | 1986-01-03 | 98 |
Recalls for JLA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-26.
Frequently asked questions
What is FDA product code JLA?
JLA is the FDA product code for conversion to creatinine, creatine. It is a Class I device, regulated under 21 CFR 862.1210 and reviewed by the Clinical Chemistry panel.
What device class is JLA?
Class I, regulation 21 CFR 862.1210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JLA?
Across 2 cleared submissions the average was 300 days from receipt to decision (median 300).
Which companies have the most JLA clearances?
Panmed, Inc. (1); American Bioproducts Co. (1).
Have JLA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-11-26.
Next steps
- Run an FDA pathway report with predicate devices for product code JLA
- Run a recall and safety report across every JLA manufacturer
- Watch product code JLA 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times