FDA product code HZL: Phloxine B
HZL is the FDA product code for phloxine b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under HZL. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Phloxine 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 HZL clearance
Top HZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accra Laboratories, Inc. | 1 | 1982-12-28 |
Most recent HZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823329 | Accra Laboratories, Inc. | PAPINCOLABU STAIN EA-36/50/65 & OG-6 | 1982-12-28 | 50 |
Recalls for HZL devices
openFDA lists no recalls for product code HZL.
Frequently asked questions
What is FDA product code HZL?
HZL is the FDA product code for phloxine b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZL?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZL?
Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most HZL clearances?
Accra Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZL
- Run a recall and safety report across every HZL manufacturer
- Watch product code HZL 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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