Sodium Test Kit and Eletrolyte Cal 1 and 2
FDA 510(k) K043268 · Randox Laboratories, Ltd.
510(k) numberK043268
Submission
- Device name
- Sodium Test Kit and Eletrolyte Cal 1 and 2
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- November 26, 2004
- Decision date
- February 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEI – Uranyl Acetate/Zinc Acetate, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEI
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Questions and answers
When was Sodium Test Kit and Eletrolyte Cal 1 and 2 cleared by the FDA?
Sodium Test Kit and Eletrolyte Cal 1 and 2 (K043268) received a 510(k) decision of Substantially Equivalent on February 15, 2005, 81 days after the submission was received.
What is the product code of K043268?
The FDA product code is CEI – Uranyl Acetate/Zinc Acetate, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.