LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
FDA 510(k) clearance K033899 · decided 2004-05-20
Clearance details
- K-number
- K033899
- Device name
- LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
- Applicant
- Lifestream Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-17
- Decision date
- 2004-05-20
- Days to decision
- 155 days
- Clearance type
- Special
- Product code
- NFX
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Post Falls, ID, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.