510(k) K000494 ยท LDP Colorimetry, Acetaminophen
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 14, 2000 |
| Received | Feb 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2008 | Beckman Coulter Inc Synchron Acetaminophen (ACTM) Reagent, Part Number 472169.
ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.