510(k) K040273 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
| Applicant | Bio-Rad Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 4, 2004 |
| Received | Feb 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2010 | Vital Diagnostics, Inc. Envoy 500 Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Terminated |
JJY | None listed |
| Apr 6, 2010 | Vital Diagnostics, Inc. ATAC Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.