Whole Blood Hemoglobin Determination

FDA product code KHG · 39 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.7500
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-26 – 2023-09-29

KHG 2023-09-29

AnemoCheck Home

Applicant Sanguina, Inc.

K number K221508

View details →

KHG 2017-09-13

AnemoCheck

Applicant Sanguina, LLC

K number K163215

View details →

KHG 2004-12-15

ANEMIAPRO SELF-SCREENER

Applicant Biosafe Laboratories, Inc.

K number K042379

View details →

KHG 2002-02-11

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

Applicant Gds Technology

K number K020138

View details →

KHG 2000-08-21

CARESIDE HEMOGLOBIN

Applicant Careside, Inc.

K number K001462

View details →

KHG 2000-01-14

HEMOSITE TEST SYSTEM

Applicant Gds Technology, LLC

K number K994073

View details →

KHG 1998-08-31

HEMOSITE TEST SYSTEM

Applicant Gds Technology, LLC

K number K973649

View details →

KHG 1995-09-29

ABBOTT VISION HEMOGLOBIN (MODIFICATION)

Applicant Abbott Laboratories

K number K953221

View details →

KHG 1993-12-06

REFLOTRON HEMOGLOBIN TEST TABS

Applicant Boehringer Mannheim Corp.

K number K934064

View details →

KHG 1989-10-10

BIOTRACK HEMOGLOBIN TEST CARTRIDGE

Applicant Biotrack, Inc.

K number K895101

View details →

KHG 1989-02-24

CLINISTAT HEMOGLOBIN REAGENT TEST

Applicant Heraeus Kulzer, Inc.

K number K885227

View details →

KHG 1988-04-21

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527

Applicant Sigma Diagnostics, Inc.

K number K880038

View details →

KHG 1987-07-23

EASY-TEST HEMOGLOBIN (HGB) ITEM #16685

Applicant Em Diagnostic Systems, Inc.

K number K872653

View details →

KHG 1987-03-16

HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD

Applicant Trace Scientific , Ltd.

K number K870363

View details →

KHG 1986-09-04

TOTAL HEMOGLOBIN

Applicant J. D. Assoc.

K number K863104

View details →

KHG 1986-08-21

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)

Applicant U. S. Diagnostics, Inc.

K number K862641

View details →

KHG 1986-08-18

VISION(TM) HEMOGLOBIN

Applicant Abbott Laboratories

K number K862202

View details →

KHG 1986-06-04

ERMA HB-METER MODEL 303N

Applicant Future Impex Corp.

K number K854687

View details →

KHG 1986-03-03

HEMOGLOBIN REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K860475

View details →

KHG 1985-11-05

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB

Applicant Eastman Kodak Company

K number K854139

View details →

KHG 1985-07-16

HEMOGLOBIN ANALYZER

Applicant Awareness Technology, Inc.

K number K851467

View details →

KHG 1985-07-12

HEMOGLOBIN

Applicant Pointe Scientific, Inc.,

K number K851432

View details →

KHG 1983-09-26

EASYTOUCH HEMOGLOBIN REAGENT

Applicant Worthington Diagnostic Systems

K number K832750

View details →

KHG 1983-07-28

CO-OXIMETER CONTROL

Applicant United Diagnostics, Inc.

K number K831813

View details →

KHG 1983-04-08

REFEREE BRAND CO-OXIMETER REAGENTS

Applicant Analytical Products, Inc.

K number K830180

View details →

KHG 1983-04-05

CORNING 2500 CO-OXIMETER

Applicant Corning Medical & Scientific

K number K830590

View details →

KHG 1982-11-22

HEMOGLOBIN REAGENT

Applicant Biorent Diagnostic, Inc.

K number K823060

View details →

KHG 1982-07-30

SERALYZER HEMOGLOBIN TEST MODULE

Applicant Miles Laboratories, Inc.

K number K822045

View details →

KHG 1982-07-30

SERALYZER HEMOGLOBIN REAGENT STRIPS

Applicant Miles Laboratories, Inc.

K number K822044

View details →

KHG 1982-06-25

HEMOGLOBIN REAGENT

Applicant Anco Medical Reagents & Assoc.

K number K821658

View details →

KHG 1982-03-26

CYANMETHEMOGLOBIN TEST

Applicant Boehringer Mannheim Corp.

K number K820596

View details →

KHG 1981-01-26

AMES SERA-PAK HEMOGLOBIN REAGENT

Applicant Miles Laboratories, Inc.

K number K803248

View details →

KHG 1980-12-31

CRC(CYANMETHEMOGLOBIN REAGENT CONCENT

Applicant R&D Systems, Inc.

K number K802268

View details →

KHG 1980-11-12

ABNORMAL HEMOGLOBIN CONTROL

Applicant Marilyn L. Amick

K number K802569

View details →

KHG 1980-11-12

HEMOGLOBIN CONTROL

Applicant Marilyn L. Amick

K number K802568

View details →

KHG 1980-07-14

HEMOGLOBIN CONTROL LEVELS

Applicant Bioscientific

K number K801268

View details →

KHG 1980-04-04

COMPUR M-1000 MINI-PHOTOMETER

Applicant Miles Laboratories, Inc.

K number K800059

View details →

KHG 1979-12-31

SANDARE CYANMETHEMOGLOBIN REAGENT

Applicant Sandare Chemical Co., Inc.

K number K792503

View details →

KHG 1976-07-26

OXIMETER, CO-, IL MODEL 282

Applicant Instrumentation Laboratory CO

K number K760208

View details →