Whole Blood Hemoglobin Determination
Hematology · 21 CFR 864.7500
Recent MDR events
5 adverse event reports on file
- COBAS B 221 <6> SYSTEMJun 24, 2026MalfunctionRoche Diagnostics1823260-2026-02509
- COBAS B 221 <6> SYSTEMAug 22, 2025MalfunctionRoche Diagnostics1823260-2025-02590
- ANEMOCHECKMar 26, 2024InjurySanguina, Inc.MW5153212
- REFLOTRON HEMOGLOBIN 30Mar 14, 2011MalfunctionRoche Diagnostics1823260-2011-01378
- B-HEMOGLOBIN PHOTOMETERSep 5, 1996MalfunctionHemocue, Inc.MW1009861
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
15 firms currently registered for this product code
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Ekf Diagnostic Gmbh
BARLEBEN/MADGEBURG Saxony-Anhalt, DE
Analytical Control Systems
Fishers, IN, US
Trinity Biotech Usa
Jamestown, NY, US
Stanbio Laboratory
Boerne, TX, US
High Technology, Inc.
North Attleboro, MA, US
Horiba Instruments Incorporated
Canton, MI, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Diamond Diagnostics Inc.
Budapest, HU
510(k) clearances
39 clearances for this product code
- Sanguina, Inc.Sep 29, 2023
K221508 · AnemoCheck Home
- Sanguina, LLCSep 13, 2017
K163215 · AnemoCheck
- Biosafe Laboratories, Inc.Dec 15, 2004
K042379 · ANEMIAPRO SELF-SCREENER
- Gds TechnologyFeb 11, 2002
K020138 · STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
- Careside, Inc.Aug 21, 2000
K001462 · CARESIDE HEMOGLOBIN
- Gds Technology, LLCJan 14, 2000
K994073 · HEMOSITE TEST SYSTEM
- Gds Technology, LLCAug 31, 1998
K973649 · HEMOSITE TEST SYSTEM
- Abbott LaboratoriesSep 29, 1995
K953221 · ABBOTT VISION HEMOGLOBIN (MODIFICATION)