Product code FKH— Gastroenterology, Urology
COMINED STANDARD SOLUTION
- Classification name
- Solution-Test Standard-Conductivity, Dialysis
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code FKH
FDA has cleared devices under product code FKH between 1981 and 2019, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2013
- 2004
- 2003
- 1986
- 1985
- 1981
Top applicants under product code FKH
Recent clearances under product code FKH
- K191496 — TDS Standard Solution
- K130100 — COMINED STANDARD SOLUTION
- K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION
- K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION
- K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE
- K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
- K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
- K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.