JJM · Osmometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2730 · Class 1
Overview
| Product Code | JJM |
|---|---|
| Device Name | Osmometer For Clinical Use |
| Regulation | 21 CFR 862.2730 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K965036 | THE ADVANCED OSMOMETER (3900) | Advanced Instruments, Inc. | Feb 20, 1997 | SESE |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Advanced Instruments, Inc. | Jul 11, 1996 | SESE |
| K925970 | MODEL 3D3 OSMOMETER | Advanced Instruments, Inc. | Jul 9, 1993 | SESE |
| K911092 | OSMOMETER MODEL 2400 | Advanced Instruments, Inc. | May 22, 1991 | SESE |
| K873642 | OSMOMETER MODEL 110 | Advanced Instruments, Inc. | Oct 20, 1987 | SESE |
| K843997 | AO-10 AUTOMATED OSMOMETER | bioMerieux, Inc. | Oct 31, 1984 | SESE |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | Kyoto Diagnostics, Inc. | Aug 17, 1984 | SESE |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | Wescor, Inc. | Mar 30, 1984 | SESE |
| K834208 | COLLOID OSMOMETER 4400 | Wescor, Inc. | Mar 23, 1984 | SESE |
| K832783 | MICRO-SAMPLE OSMOMETER 3M0 | Advanced Instruments, Inc. | Nov 28, 1983 | SESE |
| K811179 | OSMOMETER MODEL OM-6010 | Fiske Med Science | May 15, 1981 | SESE |
| K790611 | OSMOMETER MODEL 3W11 | Advanced Instruments, Inc. | Jun 15, 1979 | SESE |
Top Applicants
- Advanced Instruments, Inc. — 7 clearances
- Wescor, Inc. — 2 clearances
- Fiske Med Science — 1 clearance
- Kyoto Diagnostics, Inc. — 1 clearance
- bioMerieux, Inc. — 1 clearance
