Company
PerkinElmer Life and Analytical Sciences, Wallac, OY
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)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 |
| KHO | Fluorometer, For Clinical Use | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 1 |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | 1 |
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) |
|---|---|---|---|
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG). Open, Classified |
JHJ | K862044 |
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG). Open, Classified |
JHJ | K862044 |
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum. Open, Classified |
JHJ | K862044 |
| Nov 17, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)
Specimen Gate Screening Center is used for data management of neonatal screenin Terminated |
JQP | None listed |
| Nov 2, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184
(01)06438147295708(17)180531(10)653414
(01)06438147295708(17)180531(10)6 Terminated |
NQL | K083130 |
| Sep 25, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)1904 Terminated |
JNO | K110274 |
| Mar 13, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Specimen Gate Laboratory; Product Number: 5002-0180
Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Terminated |
JQP | None listed |
| Jan 27, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Spare Disk Remover Module; Product Number: 61001820
Intended for in vitro quantitative and qualitative determination of analytes in body fluids. Terminated |
KHO | None listed |
| 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 | K090846 |
| 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 | K090846 |