510(k) K850390
K850390 is an FDA 510(k) premarket notification submitted by Hans J. Brouwers & Assoc. for the device "CHOLESTEROL TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Hans J. Brouwers & Assoc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1985
- Date Received
- February 1, 1985
- 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