510(k) K984152 ยท DJG Enzyme Immunoassay, Opiates
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 29, 1999 |
| Received | Nov 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984152
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2020 | Beckman Coulter Inc. Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators Terminated |
DJG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.