Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017101757

FEI Number

3017101757

Entity Name

EKF Life Sciences

City/State/Country

South Bend, IN, US

Establishment Address

6879 Enterprise Drive, Suite 500, South Bend, IN 46628, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

STANBIO LABORATORY (Owner Number: 1616487)

Owner / Operator Contact Address

1261 NORTH MAIN ST., --, Boerne, TX 78006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2014-03-19
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2011-12-30
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2011-12-30
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2020-04-29
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2014-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STANBIO LABORATORY

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1616487	STANBIO LABORATORY	Boerne, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K980032	Diagnostic Chemicals , Ltd.	SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71	1998-03-02

Similar Registrations

Registration Number	Establishment Name	Location
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1616487	STANBIO LABORATORY	Boerne, TX, US
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
8020316	Sekisui Diagnostics P.E.I. Inc.	CHARLOTTETOWN Prince Edward Island, CA
3006198300	Diamond Diagnostics Inc.	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017101757. Last updated year: 2026. Please use registration number 3017101757 when referencing this establishment in official correspondence.