Analyzer, Chemistry, Centrifugal, For Clinical Use
Clinical Chemistry · 21 CFR 862.2140
Recent MDR events
140 adverse event reports on file
- Piccolo Xpress Chemistry AnalyzerJul 31, 2026MalfunctionAbaxis, Inc.2939693-2026-00018
- PICCOLO XPRESS CHEMISTRY ANALYZERJul 17, 2026MalfunctionAbaxis, Inc.2939693-2026-00017
- PICCOLO XPRESS CHEMISTRY ANALYZERJun 26, 2026MalfunctionAbaxis, Inc.2939693-2026-00016
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 29, 2026MalfunctionAbaxis, Inc.2939693-2026-00015
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 22, 2026MalfunctionAbaxis, Inc.2939693-2026-00013
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 22, 2026MalfunctionAbaxis, Inc.2939693-2026-00014
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 19, 2026MalfunctionAbaxis, Inc.2939693-2026-00012
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 14, 2026MalfunctionAbaxis, Inc.2939693-2026-00008
- PICCOLO XPRESS CHEMISTRY ANALYZER, RECERTIFIEDMay 14, 2026MalfunctionAbaxis, Inc.2939693-2026-00011
- PICCOLO XPRESS CHEMISTRY ANALYZERMay 8, 2026MalfunctionAbaxis, Inc.2939693-2026-00009
Event type breakdown
Registered firms
15 firms currently registered for this product code
Abaxis, Inc.
UNION CITY, CA, US
Tst Biomedical Electronics Co., Ltd.
Taoyuan, TW
Q-line Biotech Limited
Lucknow Uttar Pradesh, IN
Nanning Tecbod Biological Technology Co.,ltd
Nanning Guangxi, CN
Globe Scientific, Llc
Mahwah, NJ, US
Labotek Group Corp
Bayamon, PR, US
Silfradent Srl
S.Sofia Forli, IT
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Diamond Diagnostics Inc.
Budapest, HU
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Zhejiang Lidesen Medical Instrument Co., Ltd
Hangzhou Zhejiang, CN
Accuster Technologies Pvt. Ltd.
NEW DELHI, IN
Bialex Lab
Wichita Falls, TX, US
510(k) clearances
30 clearances for this product code
- Landmark Scientific, Inc.Aug 28, 1997
K972409 · AG CHEMISTRY ANALYZER SYSTEM
- Abaxis, Inc.Mar 13, 1995
K942782 · PICCOLO(TM)
- Abaxis, Inc.Apr 6, 1994
K934592 · EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
- Olympus Corp.Jun 10, 1992
K920942 · OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER
- Roche Diagnostic Systems, Inc.Feb 27, 1991
K910222 · COBAS ALPHA
- Beckman Instruments, Inc.Oct 15, 1990
K903626 · BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
- Roche Diagnostic Systems, Inc.Aug 3, 1989
K893854 · COBAS FARA II CENTRIFUGAL ANALYZER
- Roche Diagnostic Systems, Inc.Jul 20, 1989
K893641 · COBAS FARA CENTRIFUGAL ANALYZER