KHG — Whole Blood Hemoglobin Determination Class II
FDA product code KHG covers "Whole Blood Hemoglobin Determination", a Class II medical device regulated under 21 CFR 864.7500. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |