510(k) K980667
K980667 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)". The FDA issued a decision of Substantially Equivalent on Apr 21, 1998. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 21, 1998
- Date Received
- Feb 20, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Enzymatic Esterase--Oxidase, Cholesterol
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- CH
- Submission Type
- 510(k) Exempt