Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003982601

FEI Number

3003982601

Entity Name

CANTERBURY SCIENTIFIC LTD.

City/State/Country

Christchurch Canterbury, NZ

Establishment Address

71 Whiteleigh Avenue, Addington, Christchurch Canterbury 8011, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CANTERBURY SCIENTIFIC LTD. (Owner Number: 9051098)

Owner / Operator Contact Address

71 Whiteleigh Avenue, Addington, Christchurch, NZ-CAN 8011, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043070

PMA Number

N/A

All Registered Proprietary Names

Hb FASC Uni-HbA1cA, Uni-HbA1cN Tosoh Bioscience Inc. Hemoglobin A1c Controls Levels 1 and 2 Siemens DCA Systems Hemoglobin A1C HbA1cAP, HbA1cNP, HbA1cP Lvl 1-n, HbA1c Lvl 1-n Liquid HbA1cA, Liquid HbA1cAP, Liquid HbA1cN, Liquid HbA1cNP, Extendsure HbA1c Liquid Controls B12396, Extendsure HbA1c Liquid Controls B12397 Siemens HbA1c Controls Atellica DCA Analyser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCM	Control, Hemoglobin, Abnormal	Hematology	Class 2	864.7415	2008-01-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-04-12

Official Correspondent

Clive Seymour

US Agent Details

Mindy McCann Business: QSERVE Group US INC. Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

CANTERBURY SCIENTIFIC LTD.

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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3010127294	Bio-Rad Laboratories Inc.	Irvine, CA, US
3007652384	MICROBIX	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003982601. Last updated year: 2026. Please use registration number 3003982601 when referencing this establishment in official correspondence.