510(k) K872295
K872295 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on Jul 16, 1987. 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
- Jul 16, 1987
- Date Received
- Jun 16, 1987
- 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