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 |