Company ยท US
Hach Co
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2017. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2017 | K162471 | Hach CM130 Chlorine Monitoring System Hach Company | PSX |
| Aug 31, 2007 | K070419 | OPACIDEN OPA REAGENT STRIPS Hach Company | JOJ |
| Dec 7, 2004 | K042322 | STERICHEK BLOOD LEAK REAGENT STRIPS Hach Company | FJD |
| Nov 15, 2004 | K040660 | STERICHEK GLUTARALDEHYDE REAGENT STRIPS Hach Company | LIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2009 | Hach Co HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA.
SteriChek Residual Peroxide Reagent Strips provide a convenien Terminated |
LIF | K974798 |
| Sep 21, 2008 | Hach Co HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bags containing 1/100-strip bottle, one medici Terminated |
FKP | K003615 |
| Sep 21, 2008 | Hach Co RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays p Terminated |
FKP | K003615 |
| Sep 21, 2008 | Hach Co HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. Th Terminated |
FKP | K003615 |
| Sep 21, 2008 | Hach Co HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles Terminated |
FKP | K003615 |