Product code KHG
- Device name
- Whole Blood Hemoglobin Determination
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7500
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221508 | AnemoCheck Home | Sanguina, Inc. | 2023-09-29 |
| K163215 | AnemoCheck | Sanguina, LLC | 2017-09-13 |
| K042379 | ANEMIAPRO SELF-SCREENER | Biosafe Laboratories, Inc. | 2004-12-15 |
| K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | Gds Technology | 2002-02-11 |
| K001462 | CARESIDE HEMOGLOBIN | Careside, Inc. | 2000-08-21 |
| K994073 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | 2000-01-14 |
| K973649 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | 1998-08-31 |
| K953221 | ABBOTT VISION HEMOGLOBIN (MODIFICATION) | Abbott Laboratories | 1995-09-29 |
| K934064 | REFLOTRON HEMOGLOBIN TEST TABS | Boehringer Mannheim Corp. | 1993-12-06 |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Biotrack, Inc. | 1989-10-10 |
| K885227 | CLINISTAT HEMOGLOBIN REAGENT TEST | Heraeus Kulzer, Inc. | 1989-02-24 |
| K880038 | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 | Sigma Diagnostics, Inc. | 1988-04-21 |
| K872653 | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 | Em Diagnostic Systems, Inc. | 1987-07-23 |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | Trace Scientific , Ltd. | 1987-03-16 |
| K863104 | TOTAL HEMOGLOBIN | J. D. Assoc. | 1986-09-04 |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | U. S. Diagnostics, Inc. | 1986-08-21 |
| K862202 | VISION(TM) HEMOGLOBIN | Abbott Laboratories | 1986-08-18 |
| K854687 | ERMA HB-METER MODEL 303N | Future Impex Corp. | 1986-06-04 |
| K860475 | HEMOGLOBIN REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-03 |
| K854139 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB | Eastman Kodak Company | 1985-11-05 |
| K851467 | HEMOGLOBIN ANALYZER | Awareness Technology, Inc. | 1985-07-16 |
| K851432 | HEMOGLOBIN | Pointe Scientific, Inc., | 1985-07-12 |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | Worthington Diagnostic Systems | 1983-09-26 |
| K831813 | CO-OXIMETER CONTROL | United Diagnostics, Inc. | 1983-07-28 |
| K830180 | REFEREE BRAND CO-OXIMETER REAGENTS | Analytical Products, Inc. | 1983-04-08 |
| K830590 | CORNING 2500 CO-OXIMETER | Corning Medical & Scientific | 1983-04-05 |
| K823060 | HEMOGLOBIN REAGENT | Biorent Diagnostic, Inc. | 1982-11-22 |
| K822044 | SERALYZER HEMOGLOBIN REAGENT STRIPS | Miles Laboratories, Inc. | 1982-07-30 |
| K822045 | SERALYZER HEMOGLOBIN TEST MODULE | Miles Laboratories, Inc. | 1982-07-30 |
| K821658 | HEMOGLOBIN REAGENT | Anco Medical Reagents & Assoc. | 1982-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048534000840 | Cleaner | EKF-diagnostic GmbH | 2022-12-21 |
| 04048534002189 | Add Pack Hemo Control DM | EKF-diagnostic GmbH | 2022-12-21 |
| 04048534002028 | Hemo Control | EKF-diagnostic GmbH | 2021-05-10 |
| 04048534000031 | Hemo Control Hemoglobin Microcuvette | EKF-diagnostic GmbH | 2021-05-10 |
| 00817869020168 | Hemoglobin Total Normal Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020236 | HemoglobinAG Philadelphia Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020229 | Hemoglobin AD Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020212 | Hemoglobin FAS Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020205 | Hemoglobin AE Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020199 | Hemoglobin A2 Elevated Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020182 | Hemoglobin A2 Normal Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020175 | Hemoglobin Total Linearity Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020151 | Hemoglobin G6PDH Intermediate Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020137 | Hemoglobin G6PDH Normal Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020052 | Hemoglobin AFSC Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020069 | Hemoglobin NAFSC Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020076 | Hemoglobin AF Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020083 | Hemoglobin AC Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020090 | Hemoglobin AS Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020106 | Hemoglobin AC Control Powder | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020113 | Hemoglobin F Normal Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020120 | Hemoglobin F Abnormal Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 00817869020144 | Hemoglobin G6PDH Deficient Control | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 05391516743136 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-19 |
| 05391516743143 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-19 |
| 05391516743150 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-19 |
| 00811727011466 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727011473 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727011480 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727014528 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |