Alkp
FDA 510(k) K981806 · Abbott Laboratories
510(k) numberK981806
Submission
- Device name
- Alkp
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- May 21, 1998
- Decision date
- June 22, 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 Alkp cleared by the FDA?
Alkp (K981806) received a 510(k) decision of Substantially Equivalent on June 22, 1998, 32 days after the submission was received.
What is the product code of K981806?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.