JBBClass II

Solubility, Hemoglobin, Abnormal

21 CFR 864.7825 / Hematology

JBB is the FDA product code for Solubility, Hemoglobin, Abnormal, a class II device type, regulated under 21 CFR 864.7825. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1993-08-16, and no recalls.

Classification record

Product code: JBB
Device name: Solubility, Hemoglobin, Abnormal
Regulation: 21 CFR 864.7825
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: 2
Ingested recalls: 0

Clearances, product code JBB

By decision year

2 clearances under product code JBB with a decision year between 1989 and 1993, 1989 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code JBB by decision year
Year	Clearances
1989	1
1993	1

Applicants with the most clearances

Product code JBB

Applicants holding the most 510(k) clearances under product code JBB
Applicant	Clearances
Histo-Med, Inc.	1
Simmler Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code JBB

Recent recalls

Product code JBB

FDA records show no recalls under product code JBB.

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)