510(k) K033899
K033899 is an FDA 510(k) premarket notification submitted by Lifestream Technologies, Inc. for the device "LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR". The FDA issued a decision of Substantially Equivalent on May 20, 2004. The device falls under product code NFX (Test, Cholesterol, Total, Over The Counter), a Class I device regulated under 21 CFR 862.1175. Lifestream Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2004
- Date Received
- December 17, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Cholesterol, Total, Over The Counter
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- TX
- Submission Type