510(k) K971788 ยท DHR System, Test, Rheumatoid Factor
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 3, 1997 |
| Received | May 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2012 | Beckman Coulter Inc. SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136
A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the r Terminated |
DHR | None listed |
| Mar 22, 2011 | Beckman Coulter Inc. SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136
RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.