Home › Device types › JJM
Osmometer For Clinical Use
FDA product code JJM · Class 1 · Clinical Chemistry
73
Registered devices
0
Adverse events
3
Recalls
12
510(k) clearances
Devices with this code
Advanced Instruments Inserts, Small Volume, Package of 100 - OsmoPRO MAX — Advanced Instruments, LLCOSMETTE XL — Precision Systems, Inc.OSMETTE XL, 105VAC, Japan — Precision Systems, Inc.OSMETTE A — Precision Systems, Inc.OSMETTE III — Precision Systems, Inc.10 ul Pipettor for OSMETTE III — Precision Systems, Inc.OSMETTE Printer Ribbon — Precision Systems, Inc.OSMETTE Sample Tubes, 2 ml, 12/pk — Precision Systems, Inc.Advanced Instrument OsmoPRO MAX — Advanced Instruments, LLCFreezePoint® Freezing Point Osmometer — ELITECHGROUP INC.OSMETTE III Probe — Precision Systems, Inc.OSMETTE Barcode Scanner with RS232 Cable — Precision Systems, Inc.Advanced Instruments A2O System Fluid — Advanced Instruments, LLCMicro-OSMETTE — Precision Systems, Inc.FreezePoint® Freezing Point Osmometer — ELITECHGROUP INC.OSMETTE Probe 0.2 & 2.0 ml — Precision Systems, Inc.OSMETTE Bath Liquid, 250ml — Precision Systems, Inc.Advanced Instruments Swab Cleaners — Advanced Instruments, LLCAdvanced Instruments Cuvettes, Package of 250 - OsmoPRO MAX — Advanced Instruments, LLCOSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkg — Precision Systems, Inc.Advanced Instruments Microsample Test Kit, Plunger Wire, 500 Tips/Cleaners — Advanced Instruments, LLCFreezePoint® Freezing Point Osmometer — ELITECHGROUP INC.OSMETTE Pipette Tips 1000/pkg 30 - 50 ul — Precision Systems, Inc.OSMETTE III with Barcode Reader, 220V — Precision Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-11 | Advanced Instruments, LLC | 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 |
| 2007-12-26 | Wescor, Inc | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. |
| 2007-12-26 | Wescor, Inc | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. |
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