510(k) K905145
K905145 is an FDA 510(k) premarket notification submitted by Biotope, Inc. for the device "ECLIPSE ICA CHOLESTEROL". The FDA issued a decision of Substantially Equivalent on February 26, 1991. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Biotope, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1991
- Date Received
- November 15, 1990
- 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