KHG · Whole Blood Hemoglobin Determination
Hematology · 21 CFR 864.7500 · Class 2
Overview
| Product Code | KHG |
|---|---|
| Device Name | Whole Blood Hemoglobin Determination |
| Regulation | 21 CFR 864.7500 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Classification Rationale
Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221508 | AnemoCheck Home | Sanguina, Inc. | Sep 29, 2023 | SESE |
| K163215 | AnemoCheck | Sanguina, LLC | Sep 13, 2017 | SESE |
| K042379 | ANEMIAPRO SELF-SCREENER | Biosafe Laboratories, Inc. | Dec 15, 2004 | SESE |
| 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 | Feb 11, 2002 | SESE |
| K001462 | CARESIDE HEMOGLOBIN | Careside, Inc. | Aug 21, 2000 | SESE |
| K994073 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | Jan 14, 2000 | SESE |
| K973649 | HEMOSITE TEST SYSTEM | Gds Technology, LLC | Aug 31, 1998 | SESE |
| K953221 | ABBOTT VISION HEMOGLOBIN (MODIFICATION) | Abbott Laboratories | Sep 29, 1995 | SESE |
| K934064 | REFLOTRON HEMOGLOBIN TEST TABS | Boehringer Mannheim Corp. | Dec 6, 1993 | SESE |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Biotrack, Inc. | Oct 10, 1989 | SESE |
| K885227 | CLINISTAT HEMOGLOBIN REAGENT TEST | Heraeus Kulzer, Inc. | Feb 24, 1989 | SESE |
| K880038 | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 | Sigma Diagnostics, Inc. | Apr 21, 1988 | SESE |
| K872653 | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 | Em Diagnostic Systems, Inc. | Jul 23, 1987 | SESE |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | Trace Scientific , Ltd. | Mar 16, 1987 | SESE |
| K863104 | TOTAL HEMOGLOBIN | J. D. Assoc. | Sep 4, 1986 | SESE |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | U. S. Diagnostics, Inc. | Aug 21, 1986 | SESE |
| K862202 | VISION(TM) HEMOGLOBIN | Abbott Laboratories | Aug 18, 1986 | SESE |
| K854687 | ERMA HB-METER MODEL 303N | Future Impex Corp. | Jun 4, 1986 | SESE |
| K860475 | HEMOGLOBIN REAGENT SET | Sterling Diagnostics, Inc. | Mar 3, 1986 | SESE |
| K854139 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB | Eastman Kodak Company | Nov 5, 1985 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 4 clearances
- Abbott Laboratories — 2 clearances
- Boehringer Mannheim Corp. — 2 clearances
- Gds Technology, LLC — 2 clearances
- Marilyn L. Amick — 2 clearances
