Data / Medical devices / New Zealand / Canterbury Scientific Ltd.
Canterbury Scientific Ltd.: FDA-registered device maker in Christchurch Canterbury, New Zealand, 3 510(k) clearances
Canterbury Scientific Ltd. is registered with the FDA (registration 3003982601) in Christchurch Canterbury, New Zealand. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 7, 2005. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003982601
- Address
- 71 Whiteleigh Avenue Addington, Christchurch Canterbury, New Zealand, 8011
- Owner or operator
- CANTERBURY SCIENTIFIC LTD. (9051098)
- Roles
- Manufacturer
- First device listed
- April 12, 2007
- Registered through
- 2026
- Brand names listed
- HBF&A2 1 Cal, HBF&A2 2 Cal with S, HBF+A2 1, HBF+A2 with S, Tosoh Bioscience Inc. Hemoglobin F and A2 Control Levels 1 and 2, Hb FASC, HbA1cAP, HbA1cNP, HbA1cP Lvl 1-n, HbA1c Lvl 1-n, 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 DCA Systems Hemoglobin A1C, Siemens HbA1c Controls Atellica DCA Analyser and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Control, Hemoglobin, Abnormal | JCM | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 2005 | K053031 | EXTENDSURE HBFASC CONTROL | JCM | Substantially Equivalent | Cantebury Scientific , Ltd. | accessdata.fda.gov |
| December 9, 2004 | K043070 | LIQUID STABLE HBA1C CONTROL | JJX | Substantially Equivalent | Canterbury Scientific , Ltd. | accessdata.fda.gov |
| June 21, 2001 | K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | JCM | Substantially Equivalent | Canterbury Health Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Calibrator, Secondary
- All makers of Control, Hemoglobin, Abnormal
Updated December 7, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.