AO-10 Automated Osmometer
FDA 510(k) K843997 · bioMerieux, Inc.
510(k) numberK843997
Submission
- Device name
- AO-10 Automated Osmometer
- Applicant
- bioMerieux, Inc.
Ivyland, PA, US - Received
- October 11, 1984
- Decision date
- October 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K965036 | The Advanced Osmometer (3900)JJM · Traditional | Advanced Instruments, Inc. | 02/20/1997SE |
| 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 |
| 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 |
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Questions and answers
When was AO-10 Automated Osmometer cleared by the FDA?
AO-10 Automated Osmometer (K843997) received a 510(k) decision of Substantially Equivalent on October 31, 1984, 20 days after the submission was received.
What is the product code of K843997?
The FDA product code is JJM – Osmometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2730.