Calibrator For Red-cell And White-cell Counting
Hematology · 21 CFR 864.8185
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
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
Clinical Diagnostic Solutions, Inc.
PLANTATION, FL, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Abbott Laboratories
Lake Forest, IL, US
Mindray Ds Usa, Inc.
Mahwah, NJ, US
R & D Systems, Inc.
MINNEAPOLIS, MN, US
Sysmex America, Inc.
Lincolnshire, IL, US
Horiba Abx Sas
MONTPELLIER Herault, FR
Horiba Instruments Incorporated
Canton, MI, US
Jas Diagnostics/drew Scientific
Plantation, FL, US
Abbott Laboratories
Irving, TX, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Streck Llc
La Vista, NE, US
Beckman Coulter, Inc.
Miami, FL, US
Sts Corporation
Duluth, GA, US
Shenzhen Mindray Bio-medical Electronics Co.,ltd
SHENZHEN Guangdong, CN
Sysmex Corporation Techno Park
KOBE Hyogo, JP
510(k) clearances
8 clearances for this product code
- Streck Laboratories, Inc.Dec 15, 1994
K943268 · SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
- R&D Systems, Inc.Jan 2, 1990
K897060 · CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
- R&D Systems, Inc.May 2, 1988
K881161 · TECH-CAL(TM)/MULTIPLE
- Technicon Instruments Corp.Feb 6, 1987
K864664 · H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
- R&D Systems, Inc.Feb 13, 1986
K854823 · CBC-CAL/MULTIPLE
- Hematology Marketing Assoc.Mar 5, 1985
K844708 · TRI-COUNT CALIBRATOR
- American DadeFeb 22, 1982
K813530 · HEMOTOLOGY CALIBRATOR
- Coulter Electronics, Inc.Feb 4, 1982
K813375 · HEMATOLOGY CALIBRATOR S-CAL