FDA product code JHN: Turbidimetric Method, Lipoproteins
JHN is the FDA product code for turbidimetric method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under JHN, from 4 different applicants. The average 510(k) review took 191 days (median 227). FDA has posted 1 recall for JHN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Turbidimetric 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 JHN clearance
Top JHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Randox Laboratories, Ltd. | 2 | 1995-09-15 |
| Olympus America, Inc. | 2 | 1995-07-05 |
| Sigma Diagnostics, Inc. | 2 | 1994-06-02 |
| Wako Chemicals USA, Inc. | 1 | 1995-09-08 |
Most recent JHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950383 | Randox Laboratories, Ltd. | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | 1995-09-15 | 227 |
| K950382 | Randox Laboratories, Ltd. | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT | 1995-09-15 | 227 |
| K952615 | Wako Chemicals USA, Inc. | WAKO AUTOKIT APO A1 | 1995-09-08 | 94 |
| K952425 | Olympus America, Inc. | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT | 1995-07-05 | 42 |
| K952466 | Olympus America, Inc. | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT | 1995-06-05 | 10 |
Recalls for JHN devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-23.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code JHN?
JHN is the FDA product code for turbidimetric 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 JHN?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JHN?
Across 7 cleared submissions the average was 191 days from receipt to decision (median 227).
Which companies have the most JHN clearances?
Randox Laboratories, Ltd. (2); Olympus America, Inc. (2); Sigma Diagnostics, Inc. (2); Wako Chemicals USA, Inc. (1).
Have JHN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JHN
- Run a recall and safety report across every JHN manufacturer
- Watch product code JHN 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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