Flow-Pac Sholesterol Reagent Set
FDA 510(k) K832780 · American Research Products Co.
510(k) numberK832780
Submission
- Device name
- Flow-Pac Sholesterol Reagent Set
- Applicant
- American Research Products Co.
Mchenry, IL, US - Received
- August 16, 1983
- Decision date
- October 14, 1983
- 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 Flow-Pac Sholesterol Reagent Set cleared by the FDA?
Flow-Pac Sholesterol Reagent Set (K832780) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 59 days after the submission was received.
What is the product code of K832780?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.