510(k) K864882 ยท JIY Photometric Method, Iron (Non-Heme)
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
| Applicant | Pointe Scientific, Inc.,, Detroit MI, US |
| Decision | Substantially Equivalent, Jan 21, 1987 |
| Received | Dec 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10 Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500.
Clinical chemistry reagent for the q Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1.
Clinical chemistry reagent for the quant Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R2.
Clinical chemistry reagent for the quantit Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL.
Clinical c Terminated |
JIY | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: 8HI904-R2-100. Terminated |
JIY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.