FDA product code HYK: Hematoxylin Harris'S
HYK is the FDA product code for hematoxylin harris's. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under HYK, from 6 different applicants. The average 510(k) review took 24 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Hematoxylin Harris'S |
| 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 HYK clearance
Top HYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accra Laboratories, Inc. | 2 | 1984-10-02 |
| Shandon, Inc. | 1 | 1987-08-21 |
| Anatech, Ltd. | 1 | 1987-07-09 |
| Surgipath | 1 | 1981-04-14 |
| Volu Sol Medical Industries | 1 | 1980-02-22 |
1 more applicants have HYK clearances. See the full list in Caduvo.
Most recent HYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873107 | Shandon, Inc. | INSTANT HEMATOXYLIN | 1987-08-21 | 14 |
| K872498 | Anatech, Ltd. | HARRIS HEMATOXYLIN | 1987-07-09 | 15 |
| K843425 | Accra Laboratories, Inc. | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | 1984-10-02 | 28 |
| K823328 | Accra Laboratories, Inc. | HARRIS HEMATOXYLIN | 1982-12-28 | 50 |
| K810733 | Surgipath | HARRIS HEMATOXYLIN | 1981-04-14 | 27 |
Recalls for HYK devices
openFDA lists no recalls for product code HYK.
Frequently asked questions
What is FDA product code HYK?
HYK is the FDA product code for hematoxylin harris's. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYK?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYK?
Across 7 cleared submissions the average was 24 days from receipt to decision (median 22).
Which companies have the most HYK clearances?
Accra Laboratories, Inc. (2); Shandon, Inc. (1); Anatech, Ltd. (1); Surgipath (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYK
- Run a recall and safety report across every HYK manufacturer
- Watch product code HYK 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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