HYWClass I

Stain, Trichrome, Mallory'S

21 CFR 864.1850 / Hematology

HYW is the FDA product code for Stain, Trichrome, Mallory'S, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1980-01-24, and no recalls.

Classification record

Product code: HYW
Device name: Stain, Trichrome, Mallory'S
Regulation: 21 CFR 864.1850
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code HYW

By decision year

2 clearances under product code HYW with a decision year between 1978 and 1980, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HYW by decision year
Year	Clearances
1978	1
1980	1

Applicants with the most clearances

Product code HYW

Applicants holding the most 510(k) clearances under product code HYW
Applicant	Clearances
Marion Laboratories, Inc.	1
Meridian Diagnostics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code HYW

Recent recalls

Product code HYW

FDA records show no recalls under product code HYW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)