Glucose (Hexokinase) Kit
FDA 510(k) K953210 · Randox Laboratories, Ltd.
510(k) numberK953210
Submission
- Device name
- Glucose (Hexokinase) Kit
- Applicant
- Randox Laboratories, Ltd.
Crumlin, IE - Received
- July 10, 1995
- Decision date
- October 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Glucose (Hexokinase) Kit cleared by the FDA?
Glucose (Hexokinase) Kit (K953210) received a 510(k) decision of Substantially Equivalent on October 25, 1996, 473 days after the submission was received.
What is the product code of K953210?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.