Company ยท US
Perkinelmer
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2022. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | 14 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 2 |
| JIA | Enzymatic Methods, Galactose | 1 |
| JLA | Conversion To Creatinine, Creatine | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 1 |
| NAK | System, Test, Biotinidase | 1 |
| PJC | Newborn Screening Specimen Collection Paper | 1 |
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | 1 |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 1 |
| QJE | Muscular Dystrophy Newborn Screening Test | 1 |
| QUE | Spinal Muscular Atrophy Newborn Screening Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2022 | K203035 | Eonis SCID-SMA kit Perkinelmer, Inc. | PJI |
| Nov 9, 2022 | DEN200044 | Eonis SCID-SMA Kit Perkinelmer, Inc. | QUE |
| Feb 7, 2020 | K193103 | NeoBase 2 Non-derivatized MSMS Kit Perkinelmer, Inc. | NQL |
| Dec 12, 2019 | DEN180056 | GSP Neonatal Creatine Kinase - MM kit Perkinelmer, Inc. | QJE |
| Nov 6, 2019 | K190335 | GSP Neonatal Total Galactose kit Perkinelmer, Inc. | JIA |
| May 3, 2019 | K190266 | NeoLSD MSMS Kit Perkinelmer, Inc. | PQW |
| Sep 8, 2016 | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector Perkinelmer, Inc. | MQB |
| Sep 1, 2016 | K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector Perkinelmer, Inc. | MQB |
| Oct 23, 2014 | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector Perkinelmer, Inc. | MQB |
| Aug 1, 2014 | K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR Perkinelmer, Inc. | MQB |
| Mar 12, 2013 | K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES Perkinelmer, Inc. | PJC |
| Nov 28, 2012 | K122495 | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR Perkinelmer, Inc. | MQB |
| Aug 23, 2010 | K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U Perkinelmer, Inc. | NQL |
| Jun 11, 2010 | K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U Perkinelmer, Inc. | KQP |
| Mar 5, 2010 | K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 Perkinelmer, Inc. | NAK |
| Sep 3, 2009 | K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT Perkinelmer, Inc. | JLW |
| Jul 9, 2009 | K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 Perkinelmer, Inc. | NQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2016 | PerkinElmer, Inc PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960)
Item Number: 6000677.
Used with the: JANUS AUTOMATED WORKSTATION
Product Codes:
AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, A Terminated |
JQW | None listed |
| Jun 24, 2016 | PerkinElmer, Inc Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized
Item Number: 6000689.
Supplied for use with JANUS Automated Workstations:
Product Number: AJS4001 AJM4001 AJI4001, AJL4 Terminated |
JQW | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer WIZARD2 1-detector,3", 1000 samples.
Product Code: 2480-0010
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Terminated |
JJJ | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer WIZARD2 10-detector, 1000 samples.
Product Code: 2470-0200, 3470-0200.
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Terminated |
JJJ | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer WIZARD2 5-detector, 1000 samples
Product Code: 2470-0150, 3470-0150
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Terminated |
JJJ | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100.
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Terminated |
JJJ | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer ClWIZARD2 5-detector, 550 samples
Product Code: 2470-0050, 3470-0050.
The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Terminated |
JJJ | None listed |
| Jan 12, 2016 | Perkinelmer Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer Perkin Elmer WIZARD2 1-detector,3", 1000 samples
Product Code: 2480-0010
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer Perkin Elmer WIZARD2 10-detector, 1000 samples
Product Code: 2470-0200, 3470-0200
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer Perkin Elmer WIZARD2 5-detector, 1 000 samples
Product Code: 2470-0150, 3470-0150
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer Perkin Elmer WIZARD2 10-detector, 550 samples
Product Code: 2470-0100, 3470-0100
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer WIZARD2 5-detector, 550 samples
Product Code: 2470-0050, 3470-0050
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer WIZARD2 2-detector, 550 samples
Product Code: 2470-0020
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jul 20, 2015 | Perkinelmer Perkin Elmer WIZARD2 1-detector, 550 samples
Product Code: 2470-0010
The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Terminated |
JJJ | None listed |
| Jan 16, 2013 | Perkinelmer Microplate, truncated V-bottomed lots included in the
above listed products
Product Number: 1380 5465.
DBS Microplate is a general purpose 96 well microplate used in the preparation and exami Terminated |
K071649 | |
| Jan 16, 2013 | Perkinelmer DBS MICROPLATE, TRUNCATED V-BOTTOMED
Product Number: 3033-0010 Terminated |
K071649 | |
| Jan 16, 2013 | Perkinelmer NEONATAL TOTAL GALACTOSE KIT
Product Numbers: 3029-0010, 3029-001B.
This kit is intended for the quantitative determination of total galactose (galactose and gal Terminated |
JLA | K071649 |
| Jan 16, 2013 | Perkinelmer NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U.
This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino Terminated |
NQL | K083130 |
| Jan 16, 2013 | Perkinelmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
MASS SPECTROMETRY KIT
Product Number: 3026-0030.
This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitin Terminated |
JNB | K021541 |
| 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 | K090846 |