Tee Adapter 9890-FLUSH Winding 282
FDA 510(k) K833693 · Shaban Mfg. Co.
510(k) numberK833693
Submission
- Device name
- Tee Adapter 9890-FLUSH Winding 282
- Applicant
- Shaban Mfg. Co.
Mchenry, IL, US - Received
- October 18, 1983
- Decision date
- December 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKS – Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951485 | Avoximeter 4000JKS · Traditional | A-Vox Systems, Inc. | 11/06/1995SE |
| K863825 | Co-Oximeter SolutionsJKS · Traditional | D.R.G. Scientific Industries | 11/24/1986SE |
| K862253 | Il 482 Co-OximeterJKS · Traditional | Instrumentation Laboratory CO | 07/29/1986SE |
| K853990 | OSM3 HemoximeterJKS · Traditional | Radiometer America, Inc. | 12/30/1985SE |
| K833211 | Bile Salts MixtureJKS · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K832066 | Control 282JKS · Traditional | Bio-Nustics, Inc. | 09/29/1983SE |
| K780652 | Hemoglobin Check Solutions, S2100 OSM-2JKS · Traditional | The London Co. | 07/27/1978SE |
More from The London 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 Tee Adapter 9890-FLUSH Winding 282 cleared by the FDA?
Tee Adapter 9890-FLUSH Winding 282 (K833693) received a 510(k) decision of Substantially Equivalent on December 30, 1983, 73 days after the submission was received.
What is the product code of K833693?
The FDA product code is JKS – Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide, a Class I (low risk) device regulated under 21 CFR 862.3220.