FDA product code HZZ: Sudan Black B
HZZ is the FDA product code for sudan black b. 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 HZZ, from 2 different applicants. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Sudan Black B |
| 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 HZZ clearance
Top HZZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1984-10-31 |
| Electrophoresis Corp. of America | 1 | 1979-12-18 |
Most recent HZZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843684 | Sigma Chemical Co. | SIGMA SUDAN BLACK REAGENT 380-1 | 1984-10-31 | 43 |
| K792552 | Electrophoresis Corp. of America | AMIDO BLACK 10B STAIN | 1979-12-18 | 8 |
Recalls for HZZ devices
openFDA lists no recalls for product code HZZ.
Frequently asked questions
What is FDA product code HZZ?
HZZ is the FDA product code for sudan black b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZZ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZZ?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most HZZ clearances?
Sigma Chemical Co. (1); Electrophoresis Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZZ
- Run a recall and safety report across every HZZ manufacturer
- Watch product code HZZ 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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