Colloid Osmometer 4400
FDA 510(k) K834208 · Wescor, Inc.
510(k) numberK834208
Submission
- Device name
- Colloid Osmometer 4400
- Applicant
- Wescor, Inc.
Mchenry, IL, US - Received
- December 5, 1983
- Decision date
- March 23, 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 |
| 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 |
| 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 |
|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | 03/27/2013SE |
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | 03/20/2001SE |
| K863395 | Wescor Sweat.Chek Sweat Conductivity AnalyzerCGZ · Traditional | 05/24/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | 05/13/1988SE |
| K881512 | Wescor Gram Stain Pack for Model 7300 AerosprayJTS · Traditional | 04/18/1988SE |
| K880544 | Wescor Stain Concentrate for Model 7100 AerosprayGJL · Traditional | 04/01/1988SE |
| K853973 | Wescor Model 3700 Webster Sweat InducerKTB · Traditional | 10/16/1985SE |
| K834214 | Wescor 5500 Vapor Pressure OsmometerJJM · Traditional | 03/30/1984SE |
| K840472 | Sys Macroduct Sweat Collection Sys 3600KTB · Traditional | 03/19/1984SE |
| K833295 | Wescor 7100 Aerospray Slide StainerKPA · Traditional | 10/31/1983SE |
Questions and answers
When was Colloid Osmometer 4400 cleared by the FDA?
Colloid Osmometer 4400 (K834208) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 109 days after the submission was received.
What is the product code of K834208?
The FDA product code is JJM – Osmometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2730.