Labone Inc

FDA Filings

This page includes the latest FDA filings for Labone Inc. 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
PMN K040198 LABONE, INC.	LABONE COCAINE METABOLITE MICRO-PLATE EIA	2004-03-05
PMN K033601 LABONE, INC.	LABONE MICRO-PLATE COTININE EIA	2004-02-10
KDT LABONE, INC. [LABONE, LLC., d/b/a Quest Diagnostics]	Phosphate Buffered Saline for Transporting Specimens	2001-11-06

Related Finance Registrations

NCAGE Code	1KTU3	LABONE INC
CAGE Code	1KTU3	LABONE, INC
SEC	0000816151	LABONE INC of DELAWARE
SEC	0000830158	LABONE INC/ of MISSOURI