510(k) K070383 ยท JFY Enzymatic Method, Creatinine
ENZYMATIC CREATININE ASSAY (265 SERIES)
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, P.E., CA |
| Decision | Substantially Equivalent, Jun 22, 2007 |
| Received | Feb 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2009 | Diagnostic Chemicals, Ltd. DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30.
In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine. Terminated |
JFY | None listed |
| Sep 30, 2009 | Diagnostic Chemicals, Ltd. DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP. Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.