Liquid-Stat TM Ast-Uv Liquid Enzune
FDA 510(k) K821048 · Beckman Instruments, Inc.
510(k) numberK821048
Submission
- Device name
- Liquid-Stat TM Ast-Uv Liquid Enzune
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- April 15, 1982
- Decision date
- May 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
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Questions and answers
When was Liquid-Stat TM Ast-Uv Liquid Enzune cleared by the FDA?
Liquid-Stat TM Ast-Uv Liquid Enzune (K821048) received a 510(k) decision of Substantially Equivalent on May 3, 1982, 18 days after the submission was received.
What is the product code of K821048?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.