FDA product code JHQ: Nephelometric Method, Lipoproteins
JHQ is the FDA product code for nephelometric method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JHQ. The average 510(k) review took 93 days (median 93).
Classification
| Field | Value |
|---|---|
| Device name | Nephelometric Method, Lipoproteins |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JHQ clearance
Top JHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syn-Kit, Inc. | 1 | 1981-01-09 |
Most recent JHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802451 | Syn-Kit, Inc. | BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. | 1981-01-09 | 93 |
Recalls for JHQ devices
openFDA lists no recalls for product code JHQ.
Frequently asked questions
What is FDA product code JHQ?
JHQ is the FDA product code for nephelometric method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is JHQ?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JHQ?
Across 1 cleared submissions the average was 93 days from receipt to decision (median 93).
Which companies have the most JHQ clearances?
Syn-Kit, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JHQ
- Run a recall and safety report across every JHQ manufacturer
- Watch product code JHQ 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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