Drew Scientific Glycated Hemoglobin Five Level Linearity Kit
FDA 510(k) K060510 · Drew Scientific , Ltd.
510(k) numberK060510
Submission
- Device name
- Drew Scientific Glycated Hemoglobin Five Level Linearity Kit
- Applicant
- Drew Scientific , Ltd.
Barrow In Furness Cumbria, GB - Received
- February 27, 2006
- Decision date
- June 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Drew Scientific Glycated Hemoglobin Five Level Linearity Kit cleared by the FDA?
Drew Scientific Glycated Hemoglobin Five Level Linearity Kit (K060510) received a 510(k) decision of Substantially Equivalent on June 19, 2006, 112 days after the submission was received.
What is the product code of K060510?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.