HYGClass I

Glenner'S Stain

21 CFR 864.1850 / Hematology

HYG is the FDA product code for Glenner'S Stain, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1981-01-08, and no recalls.

Classification record

Product code: HYG
Device name: Glenner'S Stain
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: 1
Ingested recalls: 0

Clearances, product code HYG

By decision year

1 clearance under product code HYG with a decision year between 1981 and 1981, 1981 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HYG by decision year
Year	Clearances
1981	1

Applicants with the most clearances

Product code HYG

Applicants holding the most 510(k) clearances under product code HYG
Applicant	Clearances
Occumedics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HYG.

Recent clearances

Product code HYG

K802690Class IUltrapak Cat. #100-0251Occumedics, Inc. / cleared 1981-01-08

Recent recalls

Product code HYG

FDA records show no recalls under product code HYG.

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)