Ultrazyme Plus Alp #64962,65029&65030
FDA 510(k) K821471 · Emd Chemicals, Inc.
510(k) numberK821471
Submission
- Device name
- Ultrazyme Plus Alp #64962,65029&65030
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- May 18, 1982
- Decision date
- June 2, 1982
- 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 Ultrazyme Plus Alp #64962,65029&65030 cleared by the FDA?
Ultrazyme Plus Alp #64962,65029&65030 (K821471) received a 510(k) decision of Substantially Equivalent on June 2, 1982, 15 days after the submission was received.
What is the product code of K821471?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.