510(k) K040391 ยท CIG Diazo Colorimetry, Bilirubin
TOTAL BILIRUBIN REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Jun 2, 2004 |
| Received | Feb 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2017 | Medtest Holdings, Inc. Pointe Scientific Hitachi Total Bilirubin Rl Reagent
Product Usage:
Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitati Terminated |
CIG | None listed |
| Mar 5, 2010 | Pointe Scientific, Inc. Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250. Terminated |
CIG | None listed |
| Apr 17, 2009 | Pointe Scientific, Inc. Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI.
The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bil Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.