GHOClass I

Hemocytometer

21 CFR 864.6160 / Hematology

GHO is the FDA product code for Hemocytometer, a class I device type, regulated under 21 CFR 864.6160. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1987-05-20, and no recalls.

Classification record

Product code: GHO
Device name: Hemocytometer
Regulation: 21 CFR 864.6160
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code GHO

By decision year

2 clearances under product code GHO with a decision year between 1977 and 1987, 1977 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code GHO by decision year
Year	Clearances
1977	1
1987	1

Applicants with the most clearances

Product code GHO

Applicants holding the most 510(k) clearances under product code GHO
Applicant	Clearances
BD Becton Dickinson Vacutainer Systems Preanalytic	1
Portable Medical Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order

Recent clearances

Product code GHO

Recent recalls

Product code GHO

FDA records show no recalls under product code GHO.

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)