Hach Co
Medical device manufacturer in Ames, IA.
4510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K162471 | Hach CM130 Chlorine Monitoring SystemPSX · Traditional | 03/30/2017SE |
| K070419 | Opaciden Opa Reagent StripsJOJ · Traditional | 08/31/2007SE |
| K042322 | Sterichek Blood Leak Reagent StripsFJD · Traditional | 12/07/2004SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | 11/15/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2016-2009 | HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part…Some of the reagent strip bottles contain the incorrect strips | 04/21/2009Terminated |
| Z-2355-2008 | HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests…Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive… | 05/23/2008Terminated |
| Z-2354-2008 | RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total…Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive… | 05/23/2008Terminated |
| Z-2353-2008 | HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water…Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive… | 05/23/2008Terminated |
| Z-2352-2008 | HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests…Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive… | 05/23/2008Terminated |