FDA product code JMZ: Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
JMZ is the FDA product code for comparison of freezing points & stds. of known osmotic pressure, osmolality. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JMZ, from 2 different applicants. The average 510(k) review took 144 days (median 144).
Classification
| Field | Value |
|---|---|
| Device name | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality |
| Device class | Class I |
| Regulation | 21 CFR 862.1540 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMZ clearance
Top JMZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cenogenics Corp. | 1 | 1985-03-29 |
| Rna Medical Corp. | 1 | 1985-03-01 |
Most recent JMZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843680 | Cenogenics Corp. | URI-VAL | 1985-03-29 | 192 |
| K844589 | Rna Medical Corp. | OSMOLARITY STANDARDS | 1985-03-01 | 95 |
Recalls for JMZ devices
openFDA lists no recalls for product code JMZ.
Frequently asked questions
What is FDA product code JMZ?
JMZ is the FDA product code for comparison of freezing points & stds. of known osmotic pressure, osmolality. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel.
What device class is JMZ?
Class I, regulation 21 CFR 862.1540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMZ?
Across 2 cleared submissions the average was 144 days from receipt to decision (median 144).
Which companies have the most JMZ clearances?
Cenogenics Corp. (1); Rna Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMZ
- Run a recall and safety report across every JMZ manufacturer
- Watch product code JMZ 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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