FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
K Number: K033899
·
Decision May 20, 2004
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
155
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
- K Number
- K033899
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lifestream Technologies, Inc.
- Date Received
- December 17, 2003
- Decision Date
- May 20, 2004
- Product Code
- NFX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFX | Test, Cholesterol, Total, Over The Counter | FDA class 1 | Clinical Chemistry |