Conductivity/Tds Calibrator Solution
FDA 510(k) K033330 · Mesa Laboratories, Inc.
510(k) numberK033330
Submission
- Device name
- Conductivity/Tds Calibrator Solution
- Applicant
- Mesa Laboratories, Inc.
Lakewood, CO, US - Received
- October 16, 2003
- Decision date
- February 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKH – Solution-Test Standard-Conductivity, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FKH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191496 | TDS Standard SolutionFKH · Traditional | Mesa Laboratories, Inc. | 08/05/2019SE |
| K130100 | Comined Standard SolutionFKH · Traditional | Mesa Laboratories, Inc. | 04/18/2013SE |
| K041636 | H&S-Conductivity Standard SolutionFKH · Traditional | H & S Technical Services | 07/02/2004SE |
| K032075 | Conductivity Standard Solution-MetercareFKH · Traditional | Ibp Instruments GmbH | 09/17/2003SE |
| K863824 | Solution/Test Standard/Conduct. Dialy.&Mult.Solut.FKH · Traditional | D.R.G. Scientific Industries | 10/24/1986SE |
| K851362 | Standard Solution of Conductivity & Measurement ofFKH · Traditional | Rna Medical Corp. | 06/12/1985SE |
| K812622 | Hemodialysis Venous & Arterial SetFKH · Traditional | Amisco Trading Corp. | 09/24/1981SE |
More from Amisco Trading Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K201765 | SmartHDM-510 SystemFIZ · Special | 09/02/2020SE |
| K191496 | TDS Standard SolutionFKH · Traditional | 08/05/2019SE |
| K150657 | Phoenix XL Dialysate MeterFIZ · Traditional | 09/21/2015SE |
| K140589 | Sterrad Cyclesure 24 Plus Biological IndicatorFRC · Traditional | 12/03/2014SE |
| K130100 | Comined Standard SolutionFKH · Traditional | 04/18/2013SE |
| K122362 | Smart-Well IncubatorFRC · Special | 03/26/2013SE |
| K112018 | Smart Read Eztest SteamFRC · Traditional | 01/30/2012SE |
| K050812 | 90XL Instrumentation SystemFIZ · Special | 05/05/2005SE |
Questions and answers
When was Conductivity/Tds Calibrator Solution cleared by the FDA?
Conductivity/Tds Calibrator Solution (K033330) received a 510(k) decision of Substantially Equivalent on February 27, 2004, 134 days after the submission was received.
What is the product code of K033330?
The FDA product code is FKH – Solution-Test Standard-Conductivity, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.