The following data is part of a premarket notification filed by Drew Scientific Ltd. with the FDA for Drew Scientific Glycated Hemoglobin Five Level Linearity Kit.
| Device ID | K060510 |
| 510k Number | K060510 |
| Device Name: | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-06-19 |