Labone L L C D B A Quest Diagnostics

FDA Filings

This page includes the latest FDA filings for Labone L L C D B A Quest Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	1930987
FEI Number	1930987
Name	LABONE, INC.
Owner & Operator	LABONE, LLC., d/b/a Quest Diagnostics
Contact Address	10101 RENNER BLVD. -- Lenexa KS 66219 US
Official Correspondent	Lisa C Christo x-913-5771784-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	10101 Renner Blvd LENEXA, KS 66219 US
Establishment Type	Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PPM LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Delayed Semen Analysis Media	2019-09-03
MPQ LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Hair Collection Kit	2019-05-13
NNK LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Semen Collection Kit	2019-04-17
NNK LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Collection Device - Mitra	2019-04-17
NNK LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Collection Card Kit	2019-04-17
PVJ LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	HairCheck-DT (THC)	2018-03-05
PVH LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Quest Diagnostics Oral Fluid Oxycodone HEIA	2017-09-21
PUX LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	HairCheck-DT (Methamphetamine)	2017-09-21
PMN K152232 \| DIO LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Quest Diagnostics HairCheck-DT (Cocaine)	2016-11-21
PMN K042726 \| LCM LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Haircheck-DT PCP	2013-02-01
PMN K042725 \| DJG LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Haircheck-DT Opiates	2013-02-01
KDT LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Phosphate Buffered Saline for Transporting Specimens	2001-11-06