KHG · Class II · 21 CFR 864.7500

FDA Product Code KHG: Whole Blood Hemoglobin Determination

Leading manufacturers include Boehringer Mannheim Corp., Abbott Laboratories and Sanguina, Inc..

39
Total
39
Cleared
83d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Whole Blood Hemoglobin Determination Devices (Product Code KHG)

39 devices
1–24 of 39
Cleared Sep 29, 2023
AnemoCheck Home
K221508
Sanguina, Inc.
Hematology · 493d
Cleared Sep 29, 1995
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221
Abbott Laboratories
Hematology · 102d
Cleared Dec 06, 1993
REFLOTRON HEMOGLOBIN TEST TABS
K934064
Boehringer Mannheim Corp.
Hematology · 159d
Cleared Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653
Em Diagnostic Systems, Inc.
Hematology · 16d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202
Abbott Laboratories
Hematology · 69d
Cleared Nov 05, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139
Eastman Kodak Company
Hematology · 26d
Cleared Mar 26, 1982
CYANMETHEMOGLOBIN TEST
K820596
Boehringer Mannheim Corp.
Hematology · 22d
Cleared Jul 26, 1976
OXIMETER, CO-, IL MODEL 282
K760208
Instrumentation Laboratory CO
Hematology · 17d

About Product Code KHG - Regulatory Context

510(k) Submission Activity

39 total 510(k) submissions under product code KHG since 1976, with 39 receiving FDA clearance (average review time: 83 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.