Replacement Pump Tubing
FDA 510(k) K853621 · Shaban Mfg. Co.
510(k) numberK853621
Submission
- Device name
- Replacement Pump Tubing
- Applicant
- Shaban Mfg. Co.
Fort Myers, FL, US - Received
- August 29, 1985
- Decision date
- December 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K840468 | Partial Press. Electrode MeasurementCHL · Traditional | 03/30/1984SE |
Questions and answers
When was Replacement Pump Tubing cleared by the FDA?
Replacement Pump Tubing (K853621) received a 510(k) decision of Substantially Equivalent on December 5, 1985, 98 days after the submission was received.
What is the product code of K853621?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.