510(k) K121864 ยท PJC Newborn Screening Specimen Collection Paper
PERKINELMER 226 SAMPLE COLLECTION DEVICES
| Applicant | Perkinelmer, Inc., Greenville SC, US |
| Decision | Substantially Equivalent, Mar 12, 2013 |
| Received | Jun 26, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K121864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2017 | PerkinElmer Health Sciences, Inc. PerkinElmer 226 Sample Collection Device Terminated |
PJC | None listed |
| Jul 24, 2017 | PerkinElmer Health Sciences, Inc. PerkinElmer 226 Sample Collection Device
The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newbo Terminated |
PJC | None listed |
| Oct 18, 2013 | Perkin Elmer Health Sciences, Inc. Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900.
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.