Shaban #9850 Pump WINDINGS-9860 Filter
FDA 510(k) K832936 · Shaban Mfg. Co.
510(k) numberK832936
Submission
- Device name
- Shaban #9850 Pump WINDINGS-9860 Filter
- Applicant
- Shaban Mfg. Co.
Mchenry, IL, US - Received
- August 30, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJO – Flame Emission Photometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2540
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873603 | Finnigan Mat Incos 50JJO · Traditional | Finnigan Corp. | 09/22/1987SE |
| K862148 | Olympus Au 5000 Flame Photometer ModuleJJO · Traditional | Olympus Corp. | 09/29/1986SE |
| K843375 | Elvi 655 Flame PhotometerJJO · Traditional | Logos Scientific, Inc. | 05/20/1985SE |
| K841847 | Lithium ReagentJJO · Traditional | Reagent Laboratory, Inc. | 08/17/1984SE |
| K834226 | Flame PhotometersJJO · Traditional | Dr. Bruno Lange GmbH | 06/22/1984SE |
| K841422 | Volume Test Dye 6JJO · Traditional | Reagent Laboratory, Inc. | 05/11/1984SE |
| K841421 | Daily Wash Solution 5JJO · Traditional | Reagent Laboratory, Inc. | 05/11/1984SE |
| K840530 | Supplies for Instrumentation Lab FlameJJO · Traditional | Shaban Mfg. Co. | 03/30/1984SE |
| K840044 | Sdi Prepax Dilukit 29-1000JJO · Traditional | Scientific Distributors, Inc. | 03/09/1984SE |
| K833535 | Potassium Sodium Analysis ProductsJJO · Traditional | Shaban Mfg. Co. | 12/29/1983SE |
More from Shaban Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K853621 | Replacement Pump TubingJJE · Traditional | 12/05/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | 02/27/1985SE |
| K844781 | Membrane KITS-KC1, CO2 & 02 for Instrument-LabCHL · Traditional | 02/01/1985SE |
| K844235 | Chloride StandardJIS · Traditional | 11/20/1984SE |
| K842656 | Replacement Parts Nova Electrolyte AnalJFL · Traditional | 08/12/1984SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | 05/25/1984SE |
| K841609 | Components for Partial Pressure EleeCHL · Traditional | 05/25/1984SE |
| K840557 | Reagents & Standards Il 501 Na/KJGS · Traditional | 04/04/1984SE |
| K840530 | Supplies for Instrumentation Lab FlameJJO · Traditional | 03/30/1984SE |
Questions and answers
When was Shaban #9850 Pump WINDINGS-9860 Filter cleared by the FDA?
Shaban #9850 Pump WINDINGS-9860 Filter (K832936) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 45 days after the submission was received.
What is the product code of K832936?
The FDA product code is JJO – Flame Emission Photometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2540.