510(k) K944075 ยท DIS Enzyme Immunoassay, Barbiturate
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 29, 1994 |
| Received | Jul 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2019 | Beckman Coulter Inc. SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DA Terminated |
DIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.