The following data is part of a premarket notification filed by Canterbury Health Laboratories with the FDA for Hemoglobin F & A2 Control (beta-thalassaemia Control).
| Device ID | K011389 |
| 510k Number | K011389 |
| Device Name: | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) |
| Classification | Control, Hemoglobin, Abnormal |
| Applicant | CANTERBURY HEALTH LABORATORIES HAGLEY AVENUE Christchurch, Canterbury, NZ |
| Contact | Maurice Owen |
| Correspondent | Maurice Owen CANTERBURY HEALTH LABORATORIES HAGLEY AVENUE Christchurch, Canterbury, NZ |
| Product Code | JCM |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-06-21 |