Osmometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2730
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- Advanced Instruments, LLCOpen, ClassifiedApr 29, 2024
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine.
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Z-1696-2024 · View FDA record ↗ - Wescor, IncTerminatedMar 27, 2008
Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
Z-1350-2008 · View FDA record ↗ - Wescor, IncTerminatedMar 27, 2008
Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
Z-1351-2008 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Gonotec Gesellschaft Fuer Mess-und Regeltechnik Mbh
BERLIN, DE
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, CN
Elitechgroup Inc
LOGAN, UT, US
Scitek Global Co.,ltd
Jinan Shandong, CN
Precision Systems, Inc.
NATICK, MA, US
Infitek Co., Ltd.
Shanghai, CN
Platinum Focus Group Ltd.
London London, City of, GB
Pt Osi Electronics
Batam Centre Riau, ID
Mx3 Diagnostics, Inc.
Austin, TX, US
Labpeak Co.,ltd
Jinan Shandong, CN
Advanced Instruments, Llc
NORWOOD, MA, US
510(k) clearances
12 clearances for this product code
- Advanced Instruments, Inc.Feb 20, 1997
K965036 · THE ADVANCED OSMOMETER (3900)
- Advanced Instruments, Inc.Jul 11, 1996
K962056 · ADVANCED MICRO-OSMOMETER MODEL 3300
- Advanced Instruments, Inc.Jul 9, 1993
K925970 · MODEL 3D3 OSMOMETER
- Advanced Instruments, Inc.May 22, 1991
K911092 · OSMOMETER MODEL 2400
- Advanced Instruments, Inc.Oct 20, 1987
K873642 · OSMOMETER MODEL 110
- bioMerieux, Inc.Oct 31, 1984
K843997 · AO-10 AUTOMATED OSMOMETER
- Kyoto Diagnostics, Inc.Aug 17, 1984
K842750 · OSMOTIC PRESSURE AUTO & STAT OM-6010
- Wescor, Inc.Mar 30, 1984
K834214 · WESCOR 5500 VAPOR PRESSURE OSMOMETER