Whole Blood Hemoglobin Determination
FDA product code KHG · Class II (moderate risk) · 21 CFR 864.7500 · Hematology
39510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Miles Laboratories, Inc. 4
- Gds Technology, LLC 3
- Sanguina, LLC 2
- Marilyn L. Amick 2
- Abbott Laboratories 2
- Boehringer Mannheim Corp. 2
- Analytical Products, Inc. 1
- Future Impex Corp. 1
- Sterling Diagnostics, Inc. 1
- Eastman Kodak Company 1
- Awareness Technology, Inc. 1
- Pointe Scientific, Inc., 1
- Worthington Diagnostic Systems 1
- United Diagnostics, Inc. 1
- Instrumentation Laboratory CO 1
- Corning Medical & Scientific 1
- Biorent Diagnostic, Inc. 1
- Anco Medical Reagents & Assoc. 1
- R&D Systems, Inc. 1
- Bioscientific 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221508 | AnemoCheck HomeKHG · Traditional | Sanguina, Inc. | 09/29/2023SE |
| K163215 | AnemoCheckKHG · Traditional | Sanguina, LLC | 09/13/2017SE |
| K042379 | Anemiapro Self-ScreenerKHG · Traditional | Biosafe Laboratories, Inc. | 12/15/2004SE |
| K020138 | Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special | Gds Technology | 02/11/2002SE |
| K001462 | Careside HemoglobinKHG · Traditional | Careside, Inc. | 08/21/2000SE |
| K994073 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 01/14/2000SE |
| K973649 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 08/31/1998SE |
| K953221 | Abbott Vision Hemoglobin (Modification)KHG · Traditional | Abbott Laboratories | 09/29/1995SE |
| K934064 | Reflotron Hemoglobin Test TabsKHG · Traditional | Boehringer Mannheim Corp. | 12/06/1993SE |
| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | Biotrack, Inc. | 10/10/1989SE |
| K885227 | Clinistat Hemoglobin Reagent TestKHG · Traditional | Heraeus Kulzer, Inc. | 02/24/1989SE |
| K880038 | For the Deter. of Hemoglobin in Plasma #527KHG · Traditional | Sigma Diagnostics, Inc. | 04/21/1988SE |
| K872653 | Easy-Test Hemoglobin (HGB) Item #16685KHG · Traditional | Em Diagnostic Systems, Inc. | 07/23/1987SE |
| K870363 | Haemoglobin Reagent - Cyanmethaemoglobin MethodKHG · Traditional | Trace Scientific , Ltd. | 03/16/1987SE |
| K863104 | Total HemoglobinKHG · Traditional | J. D. Assoc. | 09/04/1986SE |
| K862641 | U.S. Diagnostic Inc. Hemoglobin Test (Dry Pack)KHG · Traditional | U. S. Diagnostics, Inc. | 08/21/1986SE |
| K862202 | Vision(Tm) HemoglobinKHG · Traditional | Abbott Laboratories | 08/18/1986SE |
| K854687 | Erma Hb-Meter Model 303NKHG · Traditional | Future Impex Corp. | 06/04/1986SE |
| K860475 | Hemoglobin Reagent SetKHG · Traditional | Sterling Diagnostics, Inc. | 03/03/1986SE |
| K854139 | Kodak Ektachem Clinical Chemistry Slide HBKHG · Traditional | Eastman Kodak Company | 11/05/1985SE |
| K851467 | Hemoglobin AnalyzerKHG · Traditional | Awareness Technology, Inc. | 07/16/1985SE |
| K851432 | HemoglobinKHG · Traditional | Pointe Scientific, Inc., | 07/12/1985SE |
| K832750 | Easytouch Hemoglobin ReagentKHG · Traditional | Worthington Diagnostic Systems | 09/26/1983SE |
| K831813 | Co-Oximeter ControlKHG · Traditional | United Diagnostics, Inc. | 07/28/1983SE |
| K830180 | Referee Brand Co-Oximeter ReagentsKHG · Traditional | Analytical Products, Inc. | 04/08/1983SE |
| K830590 | Corning 2500 Co-OximeterKHG · Traditional | Corning Medical & Scientific | 04/05/1983SE |
| K823060 | Hemoglobin ReagentKHG · Traditional | Biorent Diagnostic, Inc. | 11/22/1982SE |
| K822045 | Seralyzer Hemoglobin Test ModuleKHG · Traditional | Miles Laboratories, Inc. | 07/30/1982SE |
| K822044 | Seralyzer Hemoglobin Reagent StripsKHG · Traditional | Miles Laboratories, Inc. | 07/30/1982SE |
| K821658 | Hemoglobin ReagentKHG · Traditional | Anco Medical Reagents & Assoc. | 06/25/1982SE |
| K820596 | Cyanmethemoglobin TestKHG · Traditional | Boehringer Mannheim Corp. | 03/26/1982SE |
| K803248 | Ames Sera-Pak Hemoglobin ReagentKHG · Traditional | Miles Laboratories, Inc. | 01/26/1981SE |
| K802268 | Crc(Cyanmethemoglobin Reagent ConcentKHG · Traditional | R&D Systems, Inc. | 12/31/1980SE |
| K802569 | Abnormal Hemoglobin ControlKHG · Traditional | Marilyn L. Amick | 11/12/1980SE |
| K802568 | Hemoglobin ControlKHG · Traditional | Marilyn L. Amick | 11/12/1980SE |
| K801268 | Hemoglobin Control LevelsKHG · Traditional | Bioscientific | 07/14/1980SE |
| K800059 | Compur M-1000 Mini-PhotometerKHG · Traditional | Miles Laboratories, Inc. | 04/04/1980SE |
| K792503 | Sandare Cyanmethemoglobin ReagentKHG · Traditional | Sandare Chemical Co., Inc. | 12/31/1979SE |
| K760208 | Oximeter, Co-, Il Model 282KHG · Traditional | Instrumentation Laboratory CO | 07/26/1976SE |