510(k) K033899
- Device
- LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
- Applicant
- LIFESTREAM TECHNOLOGIES, INC.
- 510(k) number
- K033899
- Product code
- NFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-05-20
- Date received
- 2003-12-17
- Regulation
- 862.1175
- Classification name
- Test, Cholesterol, Total, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACKSON CONNOLLY
- Address
- 510 Clearwater Loop, Suite 101 Post Falls ID US 83854 83854
FDA Registration Numbers#
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary