Alkaline Phosphatase (Alkp)
FDA 510(k) K981245 · Abbott Laboratories
510(k) numberK981245
Submission
- Device name
- Alkaline Phosphatase (Alkp)
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- April 6, 1998
- Decision date
- May 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 (Alkp) cleared by the FDA?
Alkaline Phosphatase (Alkp) (K981245) received a 510(k) decision of Substantially Equivalent on May 20, 1998, 44 days after the submission was received.
What is the product code of K981245?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.