510(k) K962294 ยท JQX Nephelometer, For Clinical Use
IMMAGE IMMUNOCHEMISTRY SYSTEM
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Aug 21, 1996 |
| Received | Jun 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2011 | Beckman Coulter Inc. IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060
The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantit Terminated |
LDT | None listed |
| Aug 10, 2010 | Beckman Coulter Inc. IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650 Terminated |
JQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.