Vision Whole Blood HDL Cholesterol
FDA 510(k) K895158 · Abbott Laboratories
510(k) numberK895158
Submission
- Device name
- Vision Whole Blood HDL Cholesterol
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 10, 1989
- Decision date
- October 2, 1989
- 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 Vision Whole Blood HDL Cholesterol cleared by the FDA?
Vision Whole Blood HDL Cholesterol (K895158) received a 510(k) decision of Substantially Equivalent on October 2, 1989, 53 days after the submission was received.
What is the product code of K895158?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.