Medical Device Manufacturer · US , Indianapolis , IN

Perkinelmer, Inc.

17 submissions · 15 cleared · Since 2009
17
Total
15
Cleared
2
Denied

Perkinelmer, Inc. — FDA 510(k) Submissions

Perkinelmer, Inc. has submitted 17 FDA 510(k) premarket notifications since 2009, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Solid State X-ray Imager (flat Panel/digital Imager), System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry, Enzymatic Methods, Galactose, Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System, Muscular Dystrophy Newborn Screening Test . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Eonis SCID-SMA kit
K203035 · PJI Severe Combined... · Medical Genetics
Nov 2022 765d
Eonis SCID-SMA Kit
DEN200044 · QUE Spinal Muscular Atrophy... · Medical Genetics
Nov 2022 854d
NeoBase 2 Non-derivatized MSMS Kit
K193103 · NQL System, Test, Amino... · Chemistry
Feb 2020 91d
GSP Neonatal Creatine Kinase - MM kit
DEN180056 · QJE Muscular Dystrophy... · Chemistry
Dec 2019 427d
GSP Neonatal Total Galactose kit
K190335 · JIA Enzymatic Methods, Galactose · Chemistry
Nov 2019 265d
NeoLSD MSMS Kit
K190266 · PQW Alpha-d-galactosidase A... · Chemistry
May 2019 84d
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
K161966 · MQB Solid State X-ray Imager... · Radiology
Sep 2016 52d
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
K161942 · MQB Solid State X-ray Imager... · Radiology
Sep 2016 48d
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K142698 · MQB Solid State X-ray Imager... · Radiology
Oct 2014 31d
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
K140551 · MQB Solid State X-ray Imager... · Radiology
Aug 2014 150d
PERKINELMER 226 SAMPLE COLLECTION DEVICES
K121864 · PJC Newborn Screening... · Chemistry
Mar 2013 259d
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
K122495 · MQB Solid State X-ray Imager... · Radiology
Nov 2012 104d
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
K093916 · NQL System, Test, Amino... · Chemistry
Aug 2010 244d
GSP NEONATALGALT KIT, MODEL 3303-001U
K100101 · KQP Fluorescent Proc.... · Chemistry
Jun 2010 149d
NEONATAL BIOTINIDASE KIT, MODEL 3018
K090123 · NAK System, Test, Biotinidase · Chemistry
Mar 2010 408d
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
K090846 · JLW Radioimmunoassay,... · Chemistry
Sep 2009 157d
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
K083130 · NQL System, Test, Amino... · Chemistry
Jul 2009 259d
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