FDA product code JZW: Nephelometer
JZW is the FDA product code for nephelometer. It is a Class I device, regulated under 21 CFR 866.4540 and reviewed by the Immunology panel. FDA has cleared 11 510(k) submissions under JZW, from 8 different applicants. The average 510(k) review took 40 days (median 31). FDA has posted 1 recall for JZW devices.
Classification
| Field | Value |
|---|---|
| Device name | Nephelometer |
| Device class | Class I |
| Regulation | 21 CFR 866.4540 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZW clearance
Top JZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behring Diagnostics, Inc. | 4 | 1990-06-07 |
| Dade Behring, Inc. | 1 | 2000-09-26 |
| Incstar Corp. | 1 | 1987-09-23 |
| Unipath , Ltd. | 1 | 1987-09-23 |
| B C Medical , Ltd. | 1 | 1980-10-03 |
3 more applicants have JZW clearances. See the full list in Caduvo.
Most recent JZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001647 | Dade Behring, Inc. | BN PROSPEC SYSTEM | 2000-09-26 | 119 |
| K761234 | Behring Diagnostics, Inc. | BEHRING LASER NEPHELOMETER | 1990-06-07 | 0 |
| K892223 | Behring Diagnostics, Inc. | BEHRING NEPHELOMETER 100 | 1989-05-04 | 31 |
| K873407 | Incstar Corp. | RRT SYSTEM LASER REFLECTOMETER ANALYZER | 1987-09-23 | 29 |
| K873401 | Unipath , Ltd. | TURBOX | 1987-09-23 | 30 |
Recalls for JZW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-27.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code JZW?
JZW is the FDA product code for nephelometer. It is a Class I device, regulated under 21 CFR 866.4540 and reviewed by the Immunology panel.
What device class is JZW?
Class I, regulation 21 CFR 866.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZW?
Across 11 cleared submissions the average was 40 days from receipt to decision (median 31).
Which companies have the most JZW clearances?
Behring Diagnostics, Inc. (4); Dade Behring, Inc. (1); Incstar Corp. (1); Unipath , Ltd. (1); B C Medical , Ltd. (1).
Have JZW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JZW
- Run a recall and safety report across every JZW manufacturer
- Watch product code JZW 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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