FDA product code HYJ: Hematoxylin
HYJ is the FDA product code for hematoxylin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 14 510(k) submissions under HYJ, from 8 different applicants. The average 510(k) review took 25 days (median 22). FDA has posted 1 recall for HYJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Hematoxylin |
| 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 HYJ clearance
Top HYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 3 | 1982-06-10 |
| Anatech, Ltd. | 2 | 1987-07-09 |
| E K Ind., Inc. | 2 | 1984-08-17 |
| Sigma Chemical Co. | 2 | 1982-06-02 |
| Surgipath | 2 | 1981-04-14 |
3 more applicants have HYJ clearances. See the full list in Caduvo.
Most recent HYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872499 | Anatech, Ltd. | ANATECH HEMATOXYLIN-NORMAL STRENGTH | 1987-07-09 | 15 |
| K872500 | Anatech, Ltd. | ANATECH HEMATOXYLIN-EXTRA STRENGTH | 1987-07-09 | 15 |
| K842740 | E K Ind., Inc. | DELAFIELD HEMATOXYLIN STAIN | 1984-08-17 | 35 |
| K842741 | E K Ind., Inc. | GILL HEMATOXYLIN STAIN | 1984-08-15 | 33 |
| K831090 | Accra Laboratories, Inc. | HEMATOXYLIN GILL FORMULATION IX#56016 | 1983-06-08 | 65 |
Recalls for HYJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code HYJ?
HYJ is the FDA product code for hematoxylin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYJ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYJ?
Across 14 cleared submissions the average was 25 days from receipt to decision (median 22).
Which companies have the most HYJ clearances?
Volu Sol Medical Industries (3); Anatech, Ltd. (2); E K Ind., Inc. (2); Sigma Chemical Co. (2); Surgipath (2).
Have HYJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HYJ
- Run a recall and safety report across every HYJ manufacturer
- Watch product code HYJ 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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