510(k) K000568
K000568 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "HDL CHOLESTEROL PLUS". The FDA issued a decision of Substantially Equivalent on August 4, 2000. The device falls under product code LBT (Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2000
- Date Received
- February 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type