510(k) K897162
K897162 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "COULTER CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on March 29, 1990. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1990
- Date Received
- December 28, 1989
- 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