510(k) K203597
K203597 is an FDA 510(k) premarket notification submitted by Abbott Ireland Diagnostics Division for the device "Cholesterol2". The FDA issued a decision of Substantially Equivalent on June 30, 2022. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Abbott Ireland Diagnostics Division has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2022
- Date Received
- December 9, 2020
- 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