FDA product code JRA: Microtitrator, For Clinical Use
JRA is the FDA product code for microtitrator, for clinical use. It is a Class I device, regulated under 21 CFR 862.2680 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JRA. The average 510(k) review took 210 days (median 210).
Classification
| Field | Value |
|---|---|
| Device name | Microtitrator, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2680 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JRA clearance
Top JRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tecan U.S., Inc. | 1 | 1997-03-18 |
Most recent JRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963268 | Tecan U.S., Inc. | GENESIS RMP | 1997-03-18 | 210 |
Recalls for JRA devices
openFDA lists no recalls for product code JRA.
Frequently asked questions
What is FDA product code JRA?
JRA is the FDA product code for microtitrator, for clinical use. It is a Class I device, regulated under 21 CFR 862.2680 and reviewed by the Clinical Chemistry panel.
What device class is JRA?
Class I, regulation 21 CFR 862.2680. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRA?
Across 1 cleared submissions the average was 210 days from receipt to decision (median 210).
Which companies have the most JRA clearances?
Tecan U.S., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRA
- Run a recall and safety report across every JRA manufacturer
- Watch product code JRA 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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