Ultra Chem Enzymatic Cholesterol Oxida
FDA 510(k) K830239 · Emd Chemicals, Inc.
510(k) numberK830239
Submission
- Device name
- Ultra Chem Enzymatic Cholesterol Oxida
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- January 25, 1983
- Decision date
- April 5, 1983
- 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 Ultra Chem Enzymatic Cholesterol Oxida cleared by the FDA?
Ultra Chem Enzymatic Cholesterol Oxida (K830239) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 70 days after the submission was received.
What is the product code of K830239?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.