KHGClass II

Whole Blood Hemoglobin Determination

21 CFR 864.7500 / Hematology

KHG is the FDA product code for Whole Blood Hemoglobin Determination, a class II device type, regulated under 21 CFR 864.7500. As of 2026-09-10, FDA records hold 39 510(k) clearances under this code, the most recent dated 2023-09-29, and one recall.

Classification record

Product code: KHG
Device name: Whole Blood Hemoglobin Determination
Regulation: 21 CFR 864.7500
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: 39
Ingested recalls: 1

Clearances, product code KHG

By decision year

39 clearances under product code KHG with a decision year between 1976 and 2023, 1980 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code KHG by decision year
Year	Clearances
1976	1
1979	1
1980	5
1981	1
1982	5
1983	4
1985	3
1986	5
1987	2
1988	1
1989	2
1993	1
1995	1
1998	1
2000	2
2002	1
2004	1
2017	1
2023	1

Applicants with the most clearances

Product code KHG

Applicants holding the most 510(k) clearances under product code KHG
Applicant	Clearances
Miles Laboratories, Inc.	4
Gds Technology, LLC	3
Abbott Medical	2
Boehringer Mannheim Corp.	2
Marilyn L. Amick	2
Sanguina, Inc.	2
Analytical Products, Inc.	1
Anco Medical Reagents & Assoc.	1
Awareness Technology, Inc.	1
Biorent Diagnostic, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code