510(k) K031002 ยท DJG Enzyme Immunoassay, Opiates
SYNCHRON SYSTEMS OPIATE REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 29, 2003 |
| Received | Mar 31, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2020 | Beckman Coulter Inc. Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening Terminated |
DJG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.