510(k) K954933 ยท LDP Colorimetry, Acetaminophen
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 18, 1995 |
| Received | Oct 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954933
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274
VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.