The following data is part of a premarket notification filed by Canterbury Scientific Ltd. with the FDA for Liquid Stable Hba1c Control.
| Device ID | K043070 |
| 510k Number | K043070 |
| Device Name: | LIQUID STABLE HBA1C CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CANTERBURY SCIENTIFIC LTD. 14 POPE STREET Christchurch, Canterbury, NZ 8001 |
| Contact | Maurice Owen |
| Correspondent | Maurice Owen CANTERBURY SCIENTIFIC LTD. 14 POPE STREET Christchurch, Canterbury, NZ 8001 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-09 |
| Summary: | summary |