Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit
FDA 510(k) K043378 · Drew Scientific , Ltd.
510(k) numberK043378
Submission
- Device name
- Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit
- Applicant
- Drew Scientific , Ltd.
Barrow In Furness Cumbria, GB - Received
- December 8, 2004
- Decision date
- December 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit cleared by the FDA?
Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit (K043378) received a 510(k) decision of Substantially Equivalent on December 29, 2004, 21 days after the submission was received.
What is the product code of K043378?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.