Control, Hematocrit
Hematology · 21 CFR 864.8625
Recent MDR events
7 adverse event reports on file
- CHEMSTATNov 23, 2020InjuryInstrumentation Laboratory Co.MW5098041
- ADVIA 120Feb 16, 2007OtherSiemens Medical Solutions Diagnostics Manufacturing Ltd.2432235-2007-00006
- ADVIA 120Feb 9, 2007OtherSiemens Medical Solutions Diagnostics2432235-2007-00003
- ADVIA 120Nov 4, 2005OtherBayer Diagnostics Mfg. Ltd.2432235-2005-00017
- ADVIA 120Aug 12, 2005OtherBayer Diagnostics Mfg Ltd2432235-2005-00013
- ADVIA 120Mar 2, 2004OtherBayer Diagnostics Mfg. Ltd.2432235-2004-00003
- BAYER ADVIA 120 SYSTEMOct 11, 2002OtherBayer Diagnostics Mfg. Ltd, Swords, Co.2432235-2002-00007
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
20 firms currently registered for this product code
Instrumentation Laboratory Co.
Bedford, MA, US
Bionostics, Inc.
Devens, MA, US
Edan Instruments, Inc.
Shenzhen Guangdong, CN
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Sts Corporation
Duluth, GA, US
Richmond Diagnostics, Inc.
North Brunswick, NJ, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Abbott Point Of Care Canada Limited
Ottawa Ontario, CA
Eurotrol B.v.
EDE Gelderland, NL
Stanbio Laboratory
Boerne, TX, US
Diamond Diagnostics Inc.
Budapest, HU
Siemens Healthcare Diagnostics Inc
East Walpole, MA, US
510(k) clearances
7 clearances for this product code
- Eurotrol B.V.May 10, 2013
K121467 · EUROTROL HEMATOCRIT CONTROL
- Bionostics, Inc.Jun 24, 2002
K021924 · MEDICA EASYQC HEMATOCRIT CONTROL
- Aalto Scientific, Ltd.May 14, 2002
K020618 · AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
- Richmond Diagnostics, Inc.Feb 20, 1997
K964452 · HEMATACHEK
- Ciba Corning Diagnostics Corp.Jul 26, 1996
K961807 · CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
- Medical Specialties, Inc.Jan 7, 1993
K924926 · MSI-HCT
- Johnson & Johnson Professionals, Inc.Jul 14, 1989
K893562 · A.QC HCT LEVEL 1 AND 2