Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038193079

FEI Number

3038193079

Entity Name

D&K Engineering Services Sdn. Bhd.

City/State/Country

Ulu Tiram Johor, MY

Establishment Address

No. 8 Jalan Indah Gemilang 6, Taman Perindustrian Gemilang, Ulu Tiram Johor 81800, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

D&K Engineering, Inc. (Owner Number: 10044530)

Owner / Operator Contact Address

15890 Bernardo Center Drive, San Diego, CA 92127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tomcat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2013-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

Dieu White Business: D&K ENGINEERING, INC. Email: dieu.white@ascentialtech.com Phone: (858) 3762265

Related Public Records

Same Entity

D&K Engineering, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005268307	D&K Engineering, Inc.	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Similar Registrations

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3015376545	IMMCO DIAGNOSTICS, INC.	Williamsville, NY, US
3005268307	D&K Engineering, Inc.	San Diego, CA, US
3016068451	LABTURBO BIOTECH CORPORATION	Taipei, TW
3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038193079. Last updated year: 2026. Please use registration number 3038193079 when referencing this establishment in official correspondence.