Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006285950

FEI Number

3004552864

Entity Name

Labcorp CLS

City/State/Country

Indianapolis, IN, US

Establishment Address

8211 SciCor Drive, Indianapolis, IN 46214, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Labcorp CLS (Owner Number: 10029208)

Owner / Operator Contact Address

8211 SciCor Drive, Indianapolis, IN 46214, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K960250

PMA Number

N/A

All Registered Proprietary Names

Greiner Sarstedt Terumo Becton Dickinson Nunc Starplex Scientific Qiagen Myriad RBM SAMCO Nalgene Corning Streck Sigma Aldrich Fisher Scientific Simport Kendal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2009-04-16

Official Correspondent

Isabelle Le Moigne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Labcorp CLS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

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1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006285950. Last updated year: 2026. Please use registration number 3006285950 when referencing this establishment in official correspondence.