Cholesterol Reagent, Automated Enzymatic
FDA 510(k) K790556 · Calbiochem-Behring Corp.
510(k) numberK790556
Submission
- Device name
- Cholesterol Reagent, Automated Enzymatic
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- March 19, 1979
- Decision date
- May 7, 1979
- 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 Cholesterol Reagent, Automated Enzymatic cleared by the FDA?
Cholesterol Reagent, Automated Enzymatic (K790556) received a 510(k) decision of Substantially Equivalent on May 7, 1979, 49 days after the submission was received.
What is the product code of K790556?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.