Immunotech Cholesterol Test
FDA 510(k) K897036 · Immunotech Corp.
510(k) numberK897036
Submission
- Device name
- Immunotech Cholesterol Test
- Applicant
- Immunotech Corp.
Boston, MA, US - Received
- December 18, 1989
- Decision date
- March 6, 1990
- 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 Immunotech Cholesterol Test cleared by the FDA?
Immunotech Cholesterol Test (K897036) received a 510(k) decision of Substantially Equivalent on March 6, 1990, 78 days after the submission was received.
What is the product code of K897036?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.