Solution-Test Standard-Conductivity, Dialysis
The Dialysis Conductivity Test Standard Solution is a reference solution used to calibrate or verify conductivity meters in hemodialysis machines to ensure accurate dialysate concentration. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKH, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.
Research product code FKH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FKH
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191496 | TDS Standard Solution | Aug 05, 2019 | Substantially Equivalent | Mesa Laboratories, Inc. |
| K130100 | COMINED STANDARD SOLUTION | Apr 18, 2013 | Substantially Equivalent | Mesa Laboratories, Inc. |
| K041636 | H&S-CONDUCTIVITY STANDARD SOLUTION | Jul 02, 2004 | Substantially Equivalent | H & S Technical Services |
| K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | Feb 27, 2004 | Substantially Equivalent | Mesa Laboratories, Inc. |
| K032075 | CONDUCTIVITY STANDARD SOLUTION-METERCARE | Sep 17, 2003 | Substantially Equivalent | Ibp Instruments GmbH |
| K863824 | SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. | Oct 24, 1986 | Substantially Equivalent | D.R.G. Scientific Industries |
| K851362 | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF | Jun 12, 1985 | Substantially Equivalent | Rna Medical Corp. |
| K812622 | HEMODIALYSIS VENOUS & ARTERIAL SET | Sep 24, 1981 | Substantially Equivalent | Amisco Trading Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.