510(k) K965108 ยท DEW Igg, Antigen, Antiserum, Control
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Dec 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2011 | Beckman Coulter Inc. SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558
The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibratio Terminated |
JIT | None listed |
| Sep 30, 2010 | Beckman Coulter Inc. SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920 Terminated |
DEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.