KHG — Whole Blood Hemoglobin Determination Class II
FDA Device Classification
Classification Details
- Product Code
- KHG
- Device Class
- Class II
- Regulation Number
- 864.7500
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K221508 | sanguina | AnemoCheck Home | September 29, 2023 |
| K163215 | sanguina | AnemoCheck | September 13, 2017 |
| K042379 | biosafe laboratories | ANEMIAPRO SELF-SCREENER | December 15, 2004 |
| K020138 | gds technology | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARD | February 11, 2002 |
| K001462 | careside | CARESIDE HEMOGLOBIN | August 21, 2000 |
| K994073 | gds technology | HEMOSITE TEST SYSTEM | January 14, 2000 |
| K973649 | gds technology | HEMOSITE TEST SYSTEM | August 31, 1998 |
| K953221 | abbott laboratories | ABBOTT VISION HEMOGLOBIN (MODIFICATION) | September 29, 1995 |
| K934064 | boehringer mannheim | REFLOTRON HEMOGLOBIN TEST TABS | December 6, 1993 |
| K895101 | biotrack | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | October 10, 1989 |
| K885227 | heraeus kulzer | CLINISTAT HEMOGLOBIN REAGENT TEST | February 24, 1989 |
| K880038 | sigma diagnostics | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 | April 21, 1988 |
| K872653 | em diagnostic systems | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 | July 23, 1987 |
| K870363 | trace scientific | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | March 16, 1987 |
| K863104 | j. d. assoc | TOTAL HEMOGLOBIN | September 4, 1986 |
| K862641 | u. s. diagnostics | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | August 21, 1986 |
| K862202 | abbott laboratories | VISION(TM) HEMOGLOBIN | August 18, 1986 |
| K854687 | future impex | ERMA HB-METER MODEL 303N | June 4, 1986 |
| K860475 | sterling diagnostics | HEMOGLOBIN REAGENT SET | March 3, 1986 |
| K854139 | eastman kodak | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB | November 5, 1985 |