FDA product code HZC: Mucicarmine
HZC is the FDA product code for mucicarmine. 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 HZC, from 2 different applicants. The average 510(k) review took 38 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Mucicarmine |
| 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 HZC clearance
Top HZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-11 |
| Sigma Chemical Co. | 1 | 1983-09-29 |
Most recent HZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842925 | E K Ind., Inc. | MUCI-CARMINE STAIN, MAYER'S FORMULA | 1984-09-11 | 48 |
| K832953 | Sigma Chemical Co. | MUCICARMINE STAIN, #HT30 | 1983-09-29 | 29 |
Recalls for HZC devices
openFDA lists no recalls for product code HZC.
Frequently asked questions
What is FDA product code HZC?
HZC is the FDA product code for mucicarmine. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZC?
Across 2 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most HZC clearances?
E K Ind., Inc. (1); Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZC
- Run a recall and safety report across every HZC manufacturer
- Watch product code HZC 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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