510(k) K003615 ยท FKP System, Dialysate Delivery, Single Patient
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
| Applicant | Environmental Test Systems, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Feb 1, 2001 |
| Received | Nov 22, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.