Alkaline Phosphatase Reagent, Dea Buff
FDA 510(k) K880796 · Trace America, Inc.
510(k) numberK880796
Submission
- Device name
- Alkaline Phosphatase Reagent, Dea Buff
- Applicant
- Trace America, Inc.
Miami, FL, US - Received
- February 26, 1988
- Decision date
- April 18, 1988
- 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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Questions and answers
When was Alkaline Phosphatase Reagent, Dea Buff cleared by the FDA?
Alkaline Phosphatase Reagent, Dea Buff (K880796) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 52 days after the submission was received.
What is the product code of K880796?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.