FDA product code HZA: Methyl Green
HZA is the FDA product code for methyl green. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under HZA, from 2 different applicants. The average 510(k) review took 46 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Methyl Green |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HZA clearance
Top HZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1987-04-29 |
| Sigma Chemical Co. | 1 | 1985-02-25 |
Most recent HZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871544 | Sigma Diagnostics, Inc. | METHYL GREEN SOLUTION | 1987-04-29 | 15 |
| K844808 | Sigma Chemical Co. | METHYL GREEN-PYRONIN STAIN PROCEDURE HT70 | 1985-02-25 | 76 |
Recalls for HZA devices
openFDA lists no recalls for product code HZA.
Frequently asked questions
What is FDA product code HZA?
HZA is the FDA product code for methyl green. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZA?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZA?
Across 2 cleared submissions the average was 46 days from receipt to decision (median 46).
Which companies have the most HZA clearances?
Sigma Diagnostics, Inc. (1); Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZA
- Run a recall and safety report across every HZA manufacturer
- Watch product code HZA 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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