Alkaline Phosphatase Reagent System
FDA 510(k) K952746 · Medical Diagnostic Technologies, Inc.
510(k) numberK952746
Submission
- Device name
- Alkaline Phosphatase Reagent System
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- June 16, 1995
- Decision date
- November 27, 1995
- 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 Reagent System cleared by the FDA?
Alkaline Phosphatase Reagent System (K952746) received a 510(k) decision of Substantially Equivalent on November 27, 1995, 164 days after the submission was received.
What is the product code of K952746?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.