Liquid-Stat Reagent for Assay of Choles.
FDA 510(k) K803254 · Beckman Instruments, Inc.
510(k) numberK803254
Submission
- Device name
- Liquid-Stat Reagent for Assay of Choles.
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- December 23, 1980
- Decision date
- January 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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Questions and answers
When was Liquid-Stat Reagent for Assay of Choles. cleared by the FDA?
Liquid-Stat Reagent for Assay of Choles. (K803254) received a 510(k) decision of Substantially Equivalent on January 9, 1981, 17 days after the submission was received.
What is the product code of K803254?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.