Panels › Gastroenterology, Urology › Product code FKH · Class 2
Solution-Test Standard-Conductivity, Dialysis
Regulation 876.5820
0510(k)s in 12 months (8 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FKH
| Company | 510(k)s | Recalls |
|---|---|---|
| Mesa Laboratories, Inc. | 3 | 1 |
| Amisco Trading Corp. | 1 | 0 |
| D.R.G. Scientific Industries | 1 | 0 |
| H & S Technical Services | 1 | 0 |
| Ibp Instruments GmbH | 1 | 0 |
| NIPRO Technical Services, Inc. | 0 | 1 |
| Rna Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2019 | K191496 | TDS Standard Solution Mesa Laboratories, Inc. | FKH |
| Apr 18, 2013 | K130100 | COMINED STANDARD SOLUTION Mesa Laboratories, Inc. | FKH |
| Jul 2, 2004 | K041636 | H&S-CONDUCTIVITY STANDARD SOLUTION H & S Technical Services | FKH |
| Feb 27, 2004 | K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION Mesa Laboratories, Inc. | FKH |
| Sep 17, 2003 | K032075 | CONDUCTIVITY STANDARD SOLUTION-METERCARE Ibp Instruments GmbH, DE | FKH |
| Oct 24, 1986 | K863824 | SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. D.R.G. Scientific Industries | FKH |
| Jun 12, 1985 | K851362 | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF Rna Medical Corp. | FKH |
| Sep 24, 1981 | K812622 | HEMODIALYSIS VENOUS & ARTERIAL SET Amisco Trading Corp. | FKH |
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