Aca High Density Lipoprotein Choles.
FDA 510(k) K792509 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK792509
Submission
- Device name
- Aca High Density Lipoprotein Choles.
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Mchenry, IL, US - Received
- December 5, 1979
- Decision date
- January 11, 1980
- 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 Aca High Density Lipoprotein Choles. cleared by the FDA?
Aca High Density Lipoprotein Choles. (K792509) received a 510(k) decision of Substantially Equivalent on January 11, 1980, 37 days after the submission was received.
What is the product code of K792509?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.