The following data is part of a premarket notification filed by Cantebury Scientific Ltd. with the FDA for Extendsure Hbfasc Control.
| Device ID | K053031 |
| 510k Number | K053031 |
| Device Name: | EXTENDSURE HBFASC CONTROL |
| Classification | Control, Hemoglobin, Abnormal |
| Applicant | CANTEBURY SCIENTIFIC LTD. 14 POPE STREET Christchurch, Canterbury, NZ 8001 |
| Contact | Maurice Owen |
| Correspondent | Maurice Owen CANTEBURY SCIENTIFIC LTD. 14 POPE STREET Christchurch, Canterbury, NZ 8001 |
| Product Code | JCM |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2005-12-07 |
| Summary: | summary |