Clinistat Cholesterol Reagent Test
FDA 510(k) K884757 · Heraeus Kulzer, Inc.
510(k) numberK884757
Submission
- Device name
- Clinistat Cholesterol Reagent Test
- Applicant
- Heraeus Kulzer, Inc.
Elkhart, IN, US - Received
- November 14, 1988
- Decision date
- March 10, 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 Clinistat Cholesterol Reagent Test cleared by the FDA?
Clinistat Cholesterol Reagent Test (K884757) received a 510(k) decision of Substantially Equivalent on March 10, 1989, 116 days after the submission was received.
What is the product code of K884757?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.