Alkaline Phosphatase (Alp) Procedure No. 245
FDA 510(k) K954840 · Sigma Diagnostics, Inc.
510(k) numberK954840
Submission
- Device name
- Alkaline Phosphatase (Alp) Procedure No. 245
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 20, 1995
- Decision date
- February 28, 1996
- 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 (Alp) Procedure No. 245 cleared by the FDA?
Alkaline Phosphatase (Alp) Procedure No. 245 (K954840) received a 510(k) decision of Substantially Equivalent on February 28, 1996, 131 days after the submission was received.
What is the product code of K954840?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.