Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009311010

FEI Number

3009311010

Entity Name

Promega Biosystems Inc.

City/State/Country

Seoul, KR

Establishment Address

#1017 A Building Gangseo-Hangang-Xi Tower, 401 Yangcheon-ro, Gangseo-gu, Seoul 07528, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Promega Corporation (Owner Number: 9036108)

Owner / Operator Contact Address

2800 Woods Hollow Road, --, Madison, WI 53711, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Maxwell CSC RNA Blood Kit Maxwell® CSC Rapid ccfDNA Kit Maxwell CSC Instrument Maxwell CSC DNA FFPE Kit Maxwell CSC Genomic DNA Kit Maxwell CSC Pathogen Total Nucleic Acid Kit Abbott mSample Preparation System DNA Maxwell CSC RNA FFPE Kit Abbott mSample Preparation System Maxwell CSC Whole Blood DNA Kit Maxwell CSC 48 Instrument Maxwell CSC Viral Total Nucleic Acid Purification Kit Maxwell® CSC XtractAll FFPE DNA/RNA Kit Maxwell CSC Blood DNA Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2011-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

Carol Lindsay Business: PROMEGA CORPORATION Email: carol.lindsay@promega.com Phone: (608) 2744330

Related Public Records

Same Entity

Promega Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2134567	Promega Corporation	Madison, WI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009311010. Last updated year: 2026. Please use registration number 3009311010 when referencing this establishment in official correspondence.