FDA product code JHR: Radioimmunoassay, Immunoglobulins (D, E)
JHR is the FDA product code for radioimmunoassay, immunoglobulins (d, e). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 9 510(k) submissions under JHR, from 6 different applicants. The average 510(k) review took 52 days (median 41). FDA has posted 2 recalls for JHR devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Immunoglobulins (D, E) |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JHR clearance
Top JHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 3 | 1996-02-14 |
| Pharmacia, Inc. | 2 | 1988-08-04 |
| Roche Diagnostics | 1 | 2006-08-31 |
| Boehringer Mannheim Corp. | 1 | 1999-02-08 |
| Ventrex Laboratories, Inc. | 1 | 1990-07-31 |
1 more applicants have JHR clearances. See the full list in Caduvo.
Most recent JHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061970 | Roche Diagnostics | ELECSYS IGE II IMMUNOASSAY | 2006-08-31 | 50 |
| K984326 | Boehringer Mannheim Corp. | ELECYS IGE ASSAY | 1999-02-08 | 67 |
| K960067 | Diagnostic Products Corp. | IMMILITE TOTAL IGE | 1996-02-14 | 40 |
| K931703 | Diagnostic Products Corp. | IMMULITE TOTAL IGE | 1993-08-16 | 132 |
| K903000 | Ventrex Laboratories, Inc. | TURBO-RAST SPECIFIC IGE ASSAY | 1990-07-31 | 22 |
Recalls for JHR devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-12-20.
Frequently asked questions
What is FDA product code JHR?
JHR is the FDA product code for radioimmunoassay, immunoglobulins (d, e). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is JHR?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHR?
Across 9 cleared submissions the average was 52 days from receipt to decision (median 41).
Which companies have the most JHR clearances?
Diagnostic Products Corp. (3); Pharmacia, Inc. (2); Roche Diagnostics (1); Boehringer Mannheim Corp. (1); Ventrex Laboratories, Inc. (1).
Have JHR devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2013-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JHR
- Run a recall and safety report across every JHR manufacturer
- Watch product code JHR 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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