510(k) K822469 ยท CIC Cresolphthalein Complexone, Calcium
PSI CALCIUM REAGENT
| Applicant | Pointe Scientific, Inc.,, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 14, 1982 |
| Received | Aug 17, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2010 | Pointe Scientific, Inc. Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC Terminated |
CIC | None listed |
| Mar 10, 2010 | Pointe Scientific, Inc. Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalo Terminated |
CIC | None listed |
| Mar 10, 2010 | Pointe Scientific, Inc. Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalo Terminated |
CIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.