Medical Device Manufacturer · US , Indianapolis , IN

Perkinelmer, Inc. - FDA 510(k) Cleared Devices

17 submissions · 15 cleared · Since 2009

17

Total

15

Cleared

2

Denied

FDA 510(k) cleared devices by Perkinelmer, Inc. Chemistry ✕

10 devices

1-10 of 10

Cleared Feb 07, 2020

NeoBase 2 Non-derivatized MSMS Kit

Chemistry · 91d

Not Cleared Dec 12, 2019

GSP Neonatal Creatine Kinase - MM kit

DEN180056 · QJE

Chemistry · 427d

Cleared Nov 06, 2019

GSP Neonatal Total Galactose kit

Chemistry · 265d

Cleared May 03, 2019

NeoLSD MSMS Kit

Chemistry · 84d

Cleared Mar 12, 2013

PERKINELMER 226 SAMPLE COLLECTION DEVICES

Chemistry · 259d

Cleared Aug 23, 2010

NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U

Chemistry · 244d

Cleared Jun 11, 2010

GSP NEONATALGALT KIT, MODEL 3303-001U

Chemistry · 149d

Cleared Mar 05, 2010

NEONATAL BIOTINIDASE KIT, MODEL 3018

Chemistry · 408d

Cleared Sep 03, 2009

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

Chemistry · 157d

Cleared Jul 09, 2009

NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040

Chemistry · 259d