510(k) K982469
K982469 is an FDA 510(k) premarket notification submitted by Elan Pharma, Inc. for the device "HICHEM CHOLESTEROL REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 19, 1998. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Elan Pharma, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1998
- Date Received
- July 15, 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