510(k) K963048 ยท DHR System, Test, Rheumatoid Factor
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Nov 4, 1996 |
| Received | Aug 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2012 | Beckman Coulter Inc. IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070
The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use Terminated |
DHR | None listed |
| Jul 27, 2011 | Beckman Coulter Inc. IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529.
Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.