The Advanced Osmometer (3900)
FDA 510(k) K965036 · Advanced Instruments, Inc.
510(k) numberK965036
Submission
- Device name
- The Advanced Osmometer (3900)
- Applicant
- Advanced Instruments, Inc.
Norwood, MA, US - Received
- December 17, 1996
- Decision date
- February 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJM – Osmometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2730
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962056 | Advanced Micro-Osmometer Model 3300JJM · Traditional | Advanced Instruments, Inc. | 07/11/1996SE |
| K925970 | Model 3D3 OsmometerJJM · Traditional | Advanced Instruments, Inc. | 07/09/1993SE |
| K911092 | Osmometer Model 2400JJM · Traditional | Advanced Instruments, Inc. | 05/22/1991SE |
| K873642 | Osmometer Model 110JJM · Traditional | Advanced Instruments, Inc. | 10/20/1987SE |
| K843997 | AO-10 Automated OsmometerJJM · Traditional | bioMerieux, Inc. | 10/31/1984SE |
| K842750 | Osmotic Pressure Auto & Stat OM-6010JJM · Traditional | Kyoto Diagnostics, Inc. | 08/17/1984SE |
| K834214 | Wescor 5500 Vapor Pressure OsmometerJJM · Traditional | Wescor, Inc. | 03/30/1984SE |
| K834208 | Colloid Osmometer 4400JJM · Traditional | Wescor, Inc. | 03/23/1984SE |
| K832783 | Micro-Sample Osmometer 3M0JJM · Traditional | Advanced Instruments, Inc. | 11/28/1983SE |
| K811179 | Osmometer Model OM-6010JJM · Traditional | Fiske Med Science | 05/15/1981SE |
More from Fiske Med Science
| 510(k) | Device | Decision |
|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | 05/27/2016SE |
| K120631 | Patient MonitorMHX · Traditional | 05/25/2012SE |
| K112465 | Vital Signs MonitorDQA · Traditional | 09/14/2011SE |
| K962056 | Advanced Micro-Osmometer Model 3300JJM · Traditional | 07/11/1996SE |
| K930526 | Intermittent Compression System Model 5000JOW · Traditional | 11/18/1993SE |
| K925970 | Model 3D3 OsmometerJJM · Traditional | 07/09/1993SE |
| K911092 | Osmometer Model 2400JJM · Traditional | 05/22/1991SE |
| K873642 | Osmometer Model 110JJM · Traditional | 10/20/1987SE |
| K863516 | Electronic Metal Locator Model MD-1 · Traditional | 09/30/1986SE |
| K842784 | CeregrotracGWQ · Traditional | 01/10/1985SE |
Questions and answers
When was The Advanced Osmometer (3900) cleared by the FDA?
The Advanced Osmometer (3900) (K965036) received a 510(k) decision of Substantially Equivalent on February 20, 1997, 65 days after the submission was received.
What is the product code of K965036?
The FDA product code is JJM – Osmometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2730.