Osmotic Pressure Auto & Stat OM-6010
FDA 510(k) K842750 · Kyoto Diagnostics, Inc.
510(k) numberK842750
Submission
- Device name
- Osmotic Pressure Auto & Stat OM-6010
- Applicant
- Kyoto Diagnostics, Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- August 17, 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 |
| K843997 | AO-10 Automated OsmometerJJM · Traditional | bioMerieux, Inc. | 10/31/1984SE |
| 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 |
|---|---|---|
| K861733 | Additional Kyotest Urine Test Reagent StripsJIL · Traditional | 07/25/1986SE |
| K843003 | Glucose Auto& Stat GA-1120CGA · Traditional | 09/28/1984SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | 07/16/1984SE |
| K841715 | Kyotest UK Urine Test Reagent StripJIN · Traditional | 05/31/1984SE |
| K841714 | Kyotest 2V, Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K841713 | Kyotest Ug Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K840828 | Kyotest 8VJMT · Traditional | 05/14/1984SE |
| K840827 | Kyotest 5VCEN · Traditional | 05/14/1984SE |
| K840996 | Urine Analyzer SystemKQO · Traditional | 05/01/1984SE |
| K840829 | Kyotest UgkJIL · Traditional | 04/19/1984SE |
Questions and answers
When was Osmotic Pressure Auto & Stat OM-6010 cleared by the FDA?
Osmotic Pressure Auto & Stat OM-6010 (K842750) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 35 days after the submission was received.
What is the product code of K842750?
The FDA product code is JJM – Osmometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2730.