FDA product code HJQ: Stereoscope, Ac-Powered
HJQ is the FDA product code for stereoscope, ac-powered. It is a Class I device, regulated under 21 CFR 886.1870 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HJQ. The average 510(k) review took 23 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Stereoscope, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1870 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HJQ clearance
Top HJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard-Allan Medical Ind., Inc. | 1 | 1983-03-24 |
Most recent HJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830625 | Richard-Allan Medical Ind., Inc. | CYTO-STAIN | 1983-03-24 | 23 |
Recalls for HJQ devices
openFDA lists no recalls for product code HJQ.
Frequently asked questions
What is FDA product code HJQ?
HJQ is the FDA product code for stereoscope, ac-powered. It is a Class I device, regulated under 21 CFR 886.1870 and reviewed by the Ophthalmic panel.
What device class is HJQ?
Class I, regulation 21 CFR 886.1870. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJQ?
Across 1 cleared submissions the average was 23 days from receipt to decision (median 23).
Which companies have the most HJQ clearances?
Richard-Allan Medical Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJQ
- Run a recall and safety report across every HJQ manufacturer
- Watch product code HJQ 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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