510(k) K935047 ยท KHO Fluorometer, For Clinical Use
AUTO DELFIA
| Applicant | Wallac OY, Finland, FI |
| Decision | Substantially Equivalent, May 23, 1994 |
| Received | Oct 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2016 | PerkinElmer Health Sciences, Inc. AutoDELFIA Plate Processor , Fluorometer, for clinical use
Product Number: 1235-5110
Product Usage:
The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assa Terminated |
KHO | None listed |
| Dec 21, 2016 | PerkinElmer Health Sciences, Inc. Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use
Product Number: 1235-8110
Product Usage:
The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perf Terminated |
KHO | None listed |
| Dec 21, 2016 | PerkinElmer Health Sciences, Inc. DELFIA PC with V3.0 Software, Fluorometer, for clinical use
Product Number: 1235-8100
Product Usage:
The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assa Terminated |
KHO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.