GHDClass I

Test, Leukocyte Alkaline Phosphatase

21 CFR 864.7660 / Hematology

GHD is the FDA product code for Test, Leukocyte Alkaline Phosphatase, a class I device type, regulated under 21 CFR 864.7660. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1990-12-18, and no recalls.

Classification record

Product code: GHD
Device name: Test, Leukocyte Alkaline Phosphatase
Regulation: 21 CFR 864.7660
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: 4
Ingested recalls: 0

Clearances, product code GHD

By decision year

4 clearances under product code GHD with a decision year between 1981 and 1990, 1990 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code GHD by decision year
Year	Clearances
1981	1
1989	1
1990	2

Applicants with the most clearances

Product code GHD

Applicants holding the most 510(k) clearances under product code GHD
Applicant	Clearances
Sigma Chemical Co.	3
Biodynamics Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code GHD

Recent recalls

Product code GHD

FDA records show no recalls under product code GHD.

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)