FDA product code HYW: Stain, Trichrome, Mallory'S
HYW is the FDA product code for stain, trichrome, mallory's. 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 HYW, from 2 different applicants. The average 510(k) review took 38 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Stain, Trichrome, Mallory'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 HYW clearance
Top HYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 1 | 1980-01-24 |
| Marion Laboratories, Inc. | 1 | 1978-08-14 |
Most recent HYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792706 | Meridian Diagnostics, Inc. | PARA-PAK(WHEATLEY'S TRICHROME STAIN) | 1980-01-24 | 28 |
| K781062 | Marion Laboratories, Inc. | DROPPER, SOLUTION TRICHROME, CEPTI-SEAL | 1978-08-14 | 49 |
Recalls for HYW devices
openFDA lists no recalls for product code HYW.
Frequently asked questions
What is FDA product code HYW?
HYW is the FDA product code for stain, trichrome, mallory's. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYW?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYW?
Across 2 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most HYW clearances?
Meridian Diagnostics, Inc. (1); Marion Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYW
- Run a recall and safety report across every HYW manufacturer
- Watch product code HYW 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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