510(k) K042243 ยท JIX Calibrator, Multi-Analyte Mixture
MICROALBUMIN MULTI-CALIBRATOR SET
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, Prince Edward, CA |
| Decision | Substantially Equivalent, Oct 4, 2004 |
| Received | Aug 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2007 | Diagnostic Chemicals, Ltd. Microalbumin Multi-Calibrator Set, in vitro diagnostic.
Catalog Number: SE-252 Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.