KHG · Class II · 21 CFR 864.7500

FDA Product Code KHG: Whole Blood Hemoglobin Determination

Leading manufacturers include Miles Laboratories, Inc., Abbott Laboratories and Marilyn L. Amick.

39
Total
39
Cleared
83d
Avg days
1976
Since
39 devices
25–39 of 39
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 Nov 22, 1982
HEMOGLOBIN REAGENT
K823060
Biorent Diagnostic, Inc.
Chemistry · 35d
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
Cleared Jun 25, 1982
HEMOGLOBIN REAGENT
K821658
Anco Medical Reagents & Assoc.
Hematology · 21d
Cleared Mar 26, 1982
CYANMETHEMOGLOBIN TEST
K820596
Boehringer Mannheim Corp.
Hematology · 22d
Cleared Jan 26, 1981
AMES SERA-PAK HEMOGLOBIN REAGENT
K803248
Miles Laboratories, Inc.
Hematology · 34d
Cleared Dec 31, 1980
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
K802268
R&D Systems, Inc.
Hematology · 106d
Cleared Nov 12, 1980
HEMOGLOBIN CONTROL
K802568
Marilyn L. Amick
Hematology · 26d
Cleared Nov 12, 1980
ABNORMAL HEMOGLOBIN CONTROL
K802569
Marilyn L. Amick
Hematology · 26d
Cleared Jul 14, 1980
HEMOGLOBIN CONTROL LEVELS
K801268
Bioscientific
Hematology · 47d
Cleared Apr 04, 1980
COMPUR M-1000 MINI-PHOTOMETER
K800059
Miles Laboratories, Inc.
Hematology · 85d
Cleared Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN REAGENT
K792503
Sandare Chemical Co., Inc.
Hematology · 27d
Cleared Jul 26, 1976
OXIMETER, CO-, IL MODEL 282
K760208
Instrumentation Laboratory CO
Hematology · 17d