Solution/Test Standard/Conduct. Dialy.&Mult.Solut.
FDA 510(k) K863824 · D.R.G. Scientific Industries
510(k) numberK863824
Submission
- Device name
- Solution/Test Standard/Conduct. Dialy.&Mult.Solut.
- Applicant
- D.R.G. Scientific Industries
East Boston, MA, US - Received
- September 30, 1986
- Decision date
- October 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K033330 | Conductivity/Tds Calibrator SolutionFKH · Traditional | Mesa Laboratories, Inc. | 02/27/2004SE |
| K032075 | Conductivity Standard Solution-MetercareFKH · Traditional | Ibp Instruments GmbH | 09/17/2003SE |
| 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.
Questions and answers
When was Solution/Test Standard/Conduct. Dialy.&Mult.Solut. cleared by the FDA?
Solution/Test Standard/Conduct. Dialy.&Mult.Solut. (K863824) received a 510(k) decision of Substantially Equivalent on October 24, 1986, 24 days after the submission was received.
What is the product code of K863824?
The FDA product code is FKH – Solution-Test Standard-Conductivity, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.