KHG · Class II · 21 CFR 864.7500

FDA Product Code KHG: Whole Blood Hemoglobin Determination

Leading manufacturers include Miles Laboratories, Inc., Gds Technology, LLC and Boehringer Mannheim Corp..

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 13, 2017
AnemoCheck
K163215
Sanguina, LLC
Hematology · 301d
Cleared Dec 15, 2004
ANEMIAPRO SELF-SCREENER
K042379
Biosafe Laboratories, Inc.
Hematology · 105d
Cleared Aug 21, 2000
CARESIDE HEMOGLOBIN
K001462
Careside, Inc.
Hematology · 103d
Cleared Jan 14, 2000
HEMOSITE TEST SYSTEM
K994073
Gds Technology, LLC
Hematology · 43d
Cleared Aug 31, 1998
HEMOSITE TEST SYSTEM
K973649
Gds Technology, LLC
Microbiology · 340d
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 Feb 24, 1989
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227
Heraeus Kulzer, Inc.
Hematology · 66d
Cleared Apr 21, 1988
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
K880038
Sigma Diagnostics, Inc.
Hematology · 107d
Cleared Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653
Em Diagnostic Systems, Inc.
Hematology · 16d
Cleared Mar 16, 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363
Trace Scientific , Ltd.
Hematology · 47d
Cleared Sep 04, 1986
TOTAL HEMOGLOBIN
K863104
J. D. Assoc.
Hematology · 21d
Cleared Aug 21, 1986
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
K862641
U. S. Diagnostics, Inc.
Hematology · 41d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202
Abbott Laboratories
Hematology · 69d
Cleared Mar 03, 1986
HEMOGLOBIN REAGENT SET
K860475
Sterling Diagnostics, Inc.
Hematology · 24d
Cleared Nov 05, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139
Eastman Kodak Company
Hematology · 26d
Cleared Jul 16, 1985
HEMOGLOBIN ANALYZER
K851467
Awareness Technology, Inc.
Hematology · 92d
Cleared Jul 12, 1985
HEMOGLOBIN
K851432
Pointe Scientific, Inc.,
Hematology · 93d
Cleared Sep 26, 1983
EASYTOUCH HEMOGLOBIN REAGENT
K832750
Worthington Diagnostic Systems
Chemistry · 42d
Cleared Apr 08, 1983
REFEREE BRAND CO-OXIMETER REAGENTS
K830180
Analytical Products, Inc.
Hematology · 80d
Cleared Apr 05, 1983
CORNING 2500 CO-OXIMETER
K830590
Corning Medical & Scientific
Hematology · 40d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045
Miles Laboratories, Inc.
Hematology · 18d

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.