GGGClass II

Guaiac Reagent

21 CFR 864.6550 / Hematology

GGG is the FDA product code for Guaiac Reagent, a class II device type, regulated under 21 CFR 864.6550. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1981-11-20, and no recalls.

Classification record

Product code: GGG
Device name: Guaiac Reagent
Regulation: 21 CFR 864.6550
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code GGG

By decision year

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

Show the numbers

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

Applicants with the most clearances

Product code GGG

Applicants holding the most 510(k) clearances under product code GGG
Applicant	Clearances
Marketing Consultants of America	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code GGG

K812603Class IITanaramaMarketing Consultants of America / cleared 1981-11-20

Recent recalls

Product code GGG

FDA records show no recalls under product code GGG.

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)