Infinity Cholesterol Reagent (Procedure No. 401)
FDA 510(k) K980667 · Sigma Diagnostics, Inc.
510(k) numberK980667
Submission
- Device name
- Infinity Cholesterol Reagent (Procedure No. 401)
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- February 20, 1998
- Decision date
- April 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Infinity Cholesterol Reagent (Procedure No. 401) cleared by the FDA?
Infinity Cholesterol Reagent (Procedure No. 401) (K980667) received a 510(k) decision of Substantially Equivalent on April 21, 1998, 60 days after the submission was received.
What is the product code of K980667?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.