Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004205692

FEI Number

3004205692

Entity Name

Response Biomedical Corp.

City/State/Country

Vancouver British Columbia, CA

Establishment Address

1781-75th Avenue W., Vancouver British Columbia V6P 6P2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Response Biomedical Corp. (Owner Number: 9046777)

Owner / Operator Contact Address

1781 - 75th Avenue W., Vancouver, CA-BC V6P 6P2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RAMP® CK-MB RAMP® Troponin I RAMP Cardiac Controls RAMP® NT-proBNP RAMP® Reader RAMP® 200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-23
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-11-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2019-12-13
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2008-08-08
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2004-07-15

Official Correspondent

Joriza Salimpade

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Response Biomedical Corp.

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
K171566	Siemens Healthcare Diagnostics, Inc.	Atellica IM High-Sensitivity Troponin I (TNIH)	2018-07-19
K182225	Siemens Healthcare Diagnostics, Inc.	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	2019-03-04
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068

Similar Registrations

Registration Number	Establishment Name	Location
2517506	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NEWARK, DE, US
3013982035	Quidel Cardiovascular Inc.	San Diego, CA, US
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
3014353045	PHC Corporation	Chiyoda-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004205692. Last updated year: 2026. Please use registration number 3004205692 when referencing this establishment in official correspondence.