GJBClass II

Thrombin

21 CFR 864.7875 / Hematology

GJB is the FDA product code for Thrombin, a class II device type, regulated under 21 CFR 864.7875. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1982-02-22, and no recalls.

Classification record

Product code: GJB
Device name: Thrombin
Regulation: 21 CFR 864.7875
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 GJB

By decision year

1 clearance under product code GJB with a decision year between 1982 and 1982, 1982 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code GJB by decision year
Year	Clearances
1982	1

Applicants with the most clearances

Product code GJB

Applicants holding the most 510(k) clearances under product code GJB
Applicant	Clearances
American Dade	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code GJB

K820084Class IIClotting Time ReagentAmerican Dade / cleared 1982-02-22

Recent recalls

Product code GJB

FDA records show no recalls under product code GJB.

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)