Product code JJM
- Device name
- Osmometer For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2730
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965036 | THE ADVANCED OSMOMETER (3900) | Advanced Instruments, Inc. | 1997-02-20 |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Advanced Instruments, Inc. | 1996-07-11 |
| K925970 | MODEL 3D3 OSMOMETER | Advanced Instruments, Inc. | 1993-07-09 |
| K911092 | OSMOMETER MODEL 2400 | Advanced Instruments, Inc. | 1991-05-22 |
| K873642 | OSMOMETER MODEL 110 | Advanced Instruments, Inc. | 1987-10-20 |
| K843997 | AO-10 AUTOMATED OSMOMETER | bioMerieux, Inc. | 1984-10-31 |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | Kyoto Diagnostics, Inc. | 1984-08-17 |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | Wescor, Inc. | 1984-03-30 |
| K834208 | COLLOID OSMOMETER 4400 | Wescor, Inc. | 1984-03-23 |
| K832783 | MICRO-SAMPLE OSMOMETER 3M0 | Advanced Instruments, Inc. | 1983-11-28 |
| K811179 | OSMOMETER MODEL OM-6010 | Fiske Med Science | 1981-05-15 |
| K790611 | OSMOMETER MODEL 3W11 | Advanced Instruments, Inc. | 1979-06-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850041049328 | OSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkg | Precision Systems, Inc. | 2023-10-14 |
| 00850041049540 | 10 ul Pipettor for OSMETTE III | Precision Systems, Inc. | 2023-10-14 |
| 00850041049533 | OSMETTE Sample Tubes, 30 ul | Precision Systems, Inc. | 2023-10-14 |
| 00850041049526 | OSMETTE III Probe | Precision Systems, Inc. | 2023-10-14 |
| 00850041049519 | Touch Micro-OSMETTE Probe | Precision Systems, Inc. | 2023-10-14 |
| 00850041049502 | OSMETTE Probe 0.2 & 2.0 ml | Precision Systems, Inc. | 2023-10-14 |
| 00850041049489 | OSMETTE III Pipette Tips & CLEANETTEs, 1/M ea/pk | Precision Systems, Inc. | 2023-10-14 |
| 00850041049441 | OSMETTE Sample Tube Rack, 50 ul | Precision Systems, Inc. | 2023-10-14 |
| 00850041049434 | Multi-OSMETTE Evaporation Shield | Precision Systems, Inc. | 2023-10-14 |
| 00850041049427 | Multi-OSMETTE Carousel, Spare | Precision Systems, Inc. | 2023-10-14 |
| 00850041049410 | OSMETTE Sample Tube Rack for 2.0 & 0.2 ml | Precision Systems, Inc. | 2023-10-14 |
| 00850041049380 | OSMETTE Sample Tubes, 30 ul | Precision Systems, Inc. | 2023-10-14 |
| 00850041049373 | OSMETTE III Plunger Tip Wire | Precision Systems, Inc. | 2023-10-14 |
| 00850041049366 | OSMETTE III 10 ul Pipet Piston 2/pk | Precision Systems, Inc. | 2023-10-14 |
| 00850041049335 | Micro-OSMETTE Stir Wires for 50 ul samples, 4/pkg | Precision Systems, Inc. | 2023-10-14 |
| 00850041049311 | CRYETTE Stir Wires, for 2 ml tubes, 4/pk | Precision Systems, Inc. | 2023-10-14 |
| 00850041049281 | Clearview Disp Sample Tubes, 0.2 ml | Precision Systems, Inc. | 2023-10-14 |
| 00850041049267 | OSMETTE Pipettor, 50 ul | Precision Systems, Inc. | 2023-10-14 |
| 00850041049243 | OSMETTE XL, 105VAC, Japan, special | Precision Systems, Inc. | 2023-10-14 |
| 00850041049236 | Micro-OSMETTE Sample Tubes, 50 ul | Precision Systems, Inc. | 2023-10-14 |
| 00850041049229 | OSMETTE Sample Tubes, 0.2 ml, 12/pk | Precision Systems, Inc. | 2023-10-14 |
| 00850041049212 | OSMETTE Sample Tubes, 2 ml, 12/pk | Precision Systems, Inc. | 2023-10-14 |
| 00850041049199 | OSMETTE XL, 105VAC, Japan | Precision Systems, Inc. | 2023-10-14 |
| 00850041049182 | Multi-OSMETTE, Extended Range, 220V | Precision Systems, Inc. | 2023-10-14 |
| 00850041049175 | Probe for Multi-OSMETTE | Precision Systems, Inc. | 2023-10-14 |
| 00850041049168 | OSMETTE III with Barcode Reader, 220V | Precision Systems, Inc. | 2023-10-14 |
| 00850041049144 | Probe for Micro-OSMETTE | Precision Systems, Inc. | 2023-10-14 |
| 10816068020600 | Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500 | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020832 | Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500 | Advanced Instruments, LLC | 2020-09-21 |
| 00816068020573 | Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes | Advanced Instruments, LLC | 2020-09-21 |