In Vitro Tests for Phosphatase & Blood Nitrogen
FDA 510(k) K852441 · Clinical Data, Inc.
510(k) numberK852441
Submission
- Device name
- In Vitro Tests for Phosphatase & Blood Nitrogen
- Applicant
- Clinical Data, Inc.
Boston, MA, US - Received
- June 10, 1985
- Decision date
- August 21, 1985
- 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 In Vitro Tests for Phosphatase & Blood Nitrogen cleared by the FDA?
In Vitro Tests for Phosphatase & Blood Nitrogen (K852441) received a 510(k) decision of Substantially Equivalent on August 21, 1985, 72 days after the submission was received.
What is the product code of K852441?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.