Centrifichem Alp/Alkaline Phosphatase
FDA 510(k) K800131 · Union Carbide Corp.
510(k) numberK800131
Submission
- Device name
- Centrifichem Alp/Alkaline Phosphatase
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- January 18, 1980
- Decision date
- February 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
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Questions and answers
When was Centrifichem Alp/Alkaline Phosphatase cleared by the FDA?
Centrifichem Alp/Alkaline Phosphatase (K800131) received a 510(k) decision of Substantially Equivalent on February 11, 1980, 24 days after the submission was received.
What is the product code of K800131?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.