Osmometer For Clinical Use

FDA product code JJM · Class I (low risk) · 21 CFR 862.2730 · Clinical Chemistry

12510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K965036The Advanced Osmometer (3900)JJM · Traditional Advanced Instruments, Inc.02/20/1997SE
K962056Advanced Micro-Osmometer Model 3300JJM · Traditional Advanced Instruments, Inc.07/11/1996SE
K925970Model 3D3 OsmometerJJM · Traditional Advanced Instruments, Inc.07/09/1993SE
K911092Osmometer Model 2400JJM · Traditional Advanced Instruments, Inc.05/22/1991SE
K873642Osmometer Model 110JJM · Traditional Advanced Instruments, Inc.10/20/1987SE
K843997AO-10 Automated OsmometerJJM · Traditional bioMerieux, Inc.10/31/1984SE
K842750Osmotic Pressure Auto & Stat OM-6010JJM · Traditional Kyoto Diagnostics, Inc.08/17/1984SE
K834214Wescor 5500 Vapor Pressure OsmometerJJM · Traditional Wescor, Inc.03/30/1984SE
K834208Colloid Osmometer 4400JJM · Traditional Wescor, Inc.03/23/1984SE
K832783Micro-Sample Osmometer 3M0JJM · Traditional Advanced Instruments, Inc.11/28/1983SE
K811179Osmometer Model OM-6010JJM · Traditional Fiske Med Science05/15/1981SE
K790611Osmometer Model 3W11JJM · Traditional Advanced Instruments, Inc.06/15/1979SE

Recalls

RecallProductFirmInitiated
Z-1696-2024 Class IIOsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of…System error messages may delay the ability to test patient samples and the need for frequent calibration… Advanced Instruments, LLC03/11/2024Open, Classified
Z-1351-2008 Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each…Inaccurate readings; The control does not provide an accurate calibration value/readings when performing… Wescor, Inc12/26/2007Terminated
Z-1350-2008 Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials…Inaccurate readings; The control does not provide an accurate calibration value/readings when performing… Wescor, Inc12/26/2007Terminated