510(k) K042330 ยท LDP Colorimetry, Acetaminophen
ACETAMINOPHEN-SL ASSAY
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, Prince Edward, CA |
| Decision | Substantially Equivalent, Jan 7, 2005 |
| Received | Aug 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2012 | Sekisui Diagnostics Llc MULTIGENT Acetaminophen for use with Architect/Aeroset
Cat. No. 2K99-20.
Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. Terminated |
LDP | None listed |
| Sep 18, 2007 | Abbott Laboratories Inc. MULTIGENT Acetaminophen, List Number 2K99-20 Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.