The following data is part of a premarket notification filed by Drew Scientific Ltd. with the FDA for Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit.
| Device ID | K043378 |
| 510k Number | K043378 |
| Device Name: | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT |
| Classification | Calibrator, Secondary |
| Applicant | DREW SCIENTIFIC LTD. SOWERBY WOODS BUSINESS PARK PARK ROAD Barrow In Furness Cumbria, GB La14 4qr |
| Contact | Diane Hill |
| Correspondent | Diane Hill DREW SCIENTIFIC LTD. SOWERBY WOODS BUSINESS PARK PARK ROAD Barrow In Furness Cumbria, GB La14 4qr |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2004-12-29 |