Alkaline Phosphatase Kit
FDA 510(k) K923507 · Randox Laboratories, Ltd.
510(k) numberK923507
Submission
- Device name
- Alkaline Phosphatase Kit
- Applicant
- Randox Laboratories, Ltd.
Antrim, N. Ireland, IR - Received
- July 15, 1992
- Decision date
- December 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Alkaline Phosphatase Kit cleared by the FDA?
Alkaline Phosphatase Kit (K923507) received a 510(k) decision of Substantially Equivalent on December 3, 1992, 141 days after the submission was received.
What is the product code of K923507?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.