FDA product code JXR: Atomic Absorption Spectrophotometer, General Use
JXR is the FDA product code for atomic absorption spectrophotometer, general use. It is a Class I device, regulated under 21 CFR 862.2850 and reviewed by the Clinical Toxicology panel. FDA has cleared 29 510(k) submissions under JXR, from 4 different applicants. The average 510(k) review took 40 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Atomic Absorption Spectrophotometer, General Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2850 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JXR clearance
Top JXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Perkin-Elmer Corp. | 17 | 1990-04-09 |
| Varian Assoc., Inc. | 6 | 1979-05-03 |
| Instrumentation Laboratory CO | 5 | 1978-05-12 |
| Ciba Corning Diagnostics Corp. | 1 | 1988-03-03 |
Most recent JXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900828 | The Perkin-Elmer Corp. | PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. | 1990-04-09 | 47 |
| K875098 | Ciba Corning Diagnostics Corp. | CIBA CORNING MODEL 644 | 1988-03-03 | 84 |
| K842752 | The Perkin-Elmer Corp. | ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT | 1984-08-22 | 37 |
| K842496 | The Perkin-Elmer Corp. | ICP/6500 INDUCTIVELY-COUPLED PLASMA- | 1984-08-10 | 45 |
| K830799 | The Perkin-Elmer Corp. | INDUCTIVELY-COUPLED PLASMA SPECTROMETER | 1983-04-12 | 29 |
Recalls for JXR devices
openFDA lists no recalls for product code JXR.
Frequently asked questions
What is FDA product code JXR?
JXR is the FDA product code for atomic absorption spectrophotometer, general use. It is a Class I device, regulated under 21 CFR 862.2850 and reviewed by the Clinical Toxicology panel.
What device class is JXR?
Class I, regulation 21 CFR 862.2850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JXR?
Across 29 cleared submissions the average was 40 days from receipt to decision (median 37).
Which companies have the most JXR clearances?
The Perkin-Elmer Corp. (17); Varian Assoc., Inc. (6); Instrumentation Laboratory CO (5); Ciba Corning Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JXR
- Run a recall and safety report across every JXR manufacturer
- Watch product code JXR 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 Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times