Company
PerkinElmer Health Sciences, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2017 | PerkinElmer Health Sciences, Inc. PerkinElmer 226 Sample Collection Device Terminated |
PJC | K121864 |
| 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 | K121864 |
| Dec 23, 2016 | PerkinElmer Health Sciences, Inc. Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0
Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, a Terminated |
JQP | None listed |
| Dec 22, 2016 | PerkinElmer Health Sciences, Inc. EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test Terminated |
PJI | 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 | K935047 |
| 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 | K935047 |
| 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 | K935047 |
| Dec 16, 2016 | PerkinElmer Health Sciences, Inc. DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum Terminated |
CGJ | K862043 |
| Aug 7, 2014 | PerkinElmer Health Sciences, Inc. PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500
Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrie Terminated |
JQP | None listed |
| Aug 6, 2014 | PerkinElmer Health Sciences, Inc. Panthera-Puncher 9 .
Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by pun Terminated |
N/A | None listed |