510(k) K970560 ยท KNK Acid, Uric, Uricase (Colorimetric)
URIC ACID (LIQUID) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Mar 11, 1997 |
| Received | Feb 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615.
For the quantitative determination of uric acid in serum on Hitachi analyzer Terminated |
KNK | None listed |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1.
For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vi Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.