The following data is part of a premarket notification filed by Canterbury Scientific Ltd. with the FDA for Hemoglobin A1c Control.
| Device ID | K021484 |
| 510k Number | K021484 |
| Device Name: | HEMOGLOBIN A1C CONTROL |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | CANTERBURY SCIENTIFIC LTD. 21 WROXTON TERRACE Christchurch, NZ |
| Contact | Maurice Owen |
| Correspondent | Maurice Owen CANTERBURY SCIENTIFIC LTD. 21 WROXTON TERRACE Christchurch, NZ |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2002-06-14 |
| Summary: | summary |