FDA product code JHC: Acid, Uric, Uricase (Oxygen Rate)
JHC is the FDA product code for acid, uric, uricase (oxygen rate). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JHC. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Uric, Uricase (Oxygen Rate) |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JHC clearance
Top JHC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Catachem, Inc. | 1 | 1986-09-29 |
Most recent JHC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863287 | Catachem, Inc. | URIC ACID (URICASE) METHOD-II | 1986-09-29 | 35 |
Recalls for JHC devices
openFDA lists no recalls for product code JHC.
Frequently asked questions
What is FDA product code JHC?
JHC is the FDA product code for acid, uric, uricase (oxygen rate). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is JHC?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JHC?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most JHC clearances?
Catachem, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JHC
- Run a recall and safety report across every JHC manufacturer
- Watch product code JHC 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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