GGHClass I

Iron Stains

21 CFR 864.1850 / Hematology

GGH is the FDA product code for Iron Stains, 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 1988-10-06, and no recalls.

Classification record

Product code: GGH
Device name: Iron Stains
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 GGH

By decision year

1 clearance under product code GGH with a decision year between 1988 and 1988, 1988 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code GGH by decision year
Year	Clearances
1988	1

Applicants with the most clearances

Product code GGH

Applicants holding the most 510(k) clearances under product code GGH
Applicant	Clearances
Scientific Device Laboratory, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order

Recent clearances

Product code GGH

K884011Class ISnap N' Stain Iron StainScientific Device Laboratory, Inc. / cleared 1988-10-06

Recent recalls

Product code GGH

FDA records show no recalls under product code GGH.

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)