510(k) K090846 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
| Applicant | Perkinelmer, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 3, 2009 |
| Received | Mar 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090846
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010
Intended for in vitro quantitative and qualitative determination of analytes in body fluids. Terminated |
KHO | None listed |
| Aug 1, 2012 | Perkinelmer Perkin Elmer Genetic Screening Processor (GSP)
Product Code: 2021-0010
Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescen Terminated |
JLW | None listed |
| Feb 28, 2012 | PerkinElmer Life and Analytical Sciences, Wallac, OY Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. Terminated |
KHO | None listed |
| Jan 11, 2012 | PerkinElmer LAS, Inc The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.