Perkinelmer, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Eonis SCID-SMA kit, NeoBase 2 Non-derivatized MSMS Kit, GSP Neonatal Total Galactose kit
17
Total
15
Cleared
2
Denied
FDA 510(k) Regulatory Record - Perkinelmer, Inc. Chemistry ✕
10 devices
Cleared
Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
Chemistry
91d
Not Cleared
Dec 12, 2019
GSP Neonatal Creatine Kinase - MM kit
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