Osmometer For Clinical Use
This device is an osmometer for clinical use that measures the osmolality of biological fluids such as serum and urine, providing information used in the assessment of fluid and electrolyte balance, renal concentrating ability, and toxic alcohol ingestion. It is classified as FDA Class 1, indicating low risk and requiring only general controls without a premarket notification. The product code is JJM, regulated under 21 CFR 862.2730, within the Clinical Chemistry medical specialty.
Basic Information
- Product Code
- JJM
- Device Class
- FDA class 1
- Regulation Number
- 862.2730
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K965036 | THE ADVANCED OSMOMETER (3900) | Feb 20, 1997 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Jul 11, 1996 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
| K925970 | MODEL 3D3 OSMOMETER | Jul 09, 1993 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
| K911092 | OSMOMETER MODEL 2400 | May 22, 1991 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
| K873642 | OSMOMETER MODEL 110 | Oct 20, 1987 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
| K843997 | AO-10 AUTOMATED OSMOMETER | Oct 31, 1984 | Substantially Equivalent | BIO MERIEUX, INC. |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | Aug 17, 1984 | Substantially Equivalent | KYOTO DIAGNOSTICS, INC. |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | Mar 30, 1984 | Substantially Equivalent | WESCOR, INC. |
| K834208 | COLLOID OSMOMETER 4400 | Mar 23, 1984 | Substantially Equivalent | WESCOR, INC. |
| K832783 | MICRO-SAMPLE OSMOMETER 3M0 | Nov 28, 1983 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
| K811179 | OSMOMETER MODEL OM-6010 | May 15, 1981 | Substantially Equivalent | FISKE MED SCIENCE |
| K790611 | OSMOMETER MODEL 3W11 | Jun 15, 1979 | Substantially Equivalent | ADVANCED INSTRUMENTS, INC. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.