510(k) K830556 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
CREATININE
| Applicant | Pointe Scientific, Inc.,, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 24, 1983 |
| Received | Feb 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2015 | Pointe Scientific, Inc. Pointe Scientific Creatinine Reagent
Catalog number C7539-150
in vitro diagnostic
C7539-150 kit includes one R1 and one R2 bottle.
R1: HDPE plastic bottle. 120 ml fill.
R2: HDPE plastic bottle. 90 Terminated |
CGX | None listed |
| Mar 9, 2010 | Pointe Scientific, Inc. Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-5 Terminated |
CGX | None listed |
| Mar 9, 2010 | Pointe Scientific, Inc. Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250.
For th Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.